Surgical instrument use indicator

ABSTRACT

An ultrasonic instrument includes a housing, an ultrasonic transducer support by the housing, and an integrated usage indicator. The housing is configured to removably connect to a shaft assembly. The ultrasonic transducer is configured to be acoustically connected to a waveguide and operated a predetermined number of use cycles. The integrated usage indicator is operatively connected to the housing and includes a used state indicator. The used state indicator is configured to indicate to a clinician in a used state when the ultrasonic transducer has been operated at least the predetermined number of use cycles for limiting usage of the ultrasonic transducer to the predetermined number of use cycles.

BACKGROUND

Ultrasonic surgical instruments utilize ultrasonic energy for bothprecise cutting and controlled coagulation of tissue. The ultrasonicenergy cuts and coagulates by vibrating a blade in contact with thetissue. Vibrating at frequencies of approximately 50 kilohertz (kHz),for example, the ultrasonic blade denatures protein in the tissue toform a sticky coagulum. Pressure exerted on the tissue with the bladesurface collapses blood vessels and allows the coagulum to form ahemostatic seal. The precision of cutting and coagulation may becontrolled by the surgeon's technique and adjusting the power level,blade edge, tissue traction, and blade pressure, for example.

Examples of ultrasonic surgical devices include the HARMONIC ACE®Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONICFOCUS® Ultrasonic Shears, and the HARMONIC SYNERGY® Ultrasonic Blades,all by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Further examplesof such devices and related concepts are disclosed in U.S. Pat. No.5,322,055, entitled “Clamp Coagulator/Cutting System for UltrasonicSurgical Instruments,” issued Jun. 21, 1994, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 5,873,873, entitled“Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Mechanism,”issued Feb. 23, 1999, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 5,980,510, entitled “Ultrasonic ClampCoagulator Apparatus Having Improved Clamp Arm Pivot Mount,” issued Nov.9, 1999, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,283,981, entitled “Method of Balancing AsymmetricUltrasonic Surgical Blades,” issued Sep. 4, 2001, the disclosure ofwhich is incorporated by reference herein; U.S. Pat. No. 6,309,400,entitled “Curved Ultrasonic Blade having a Trapezoidal Cross Section,”issued Oct. 30, 2001, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 6,325,811, entitled “Blades withFunctional Balance Asymmetries for use with Ultrasonic SurgicalInstruments,” issued Dec. 4, 2001, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,423,082, entitled“Ultrasonic Surgical Blade with Improved Cutting and CoagulationFeatures,” issued Jul. 23, 2002, the disclosure of which is incorporatedby reference herein; U.S. Pat. No. 6,773,444, entitled “Blades withFunctional Balance Asymmetries for Use with Ultrasonic SurgicalInstruments,” issued Aug. 10, 2004, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,783,524, entitled“Robotic Surgical Tool with Ultrasound Cauterizing and CuttingInstrument,” issued Aug. 31, 2004, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,057,498, entitled“Ultrasonic Surgical Instrument Blades,” issued Nov. 15, 2011, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.8,461,744, entitled “Rotating Transducer Mount for Ultrasonic SurgicalInstruments,” issued Jun. 11, 2013, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,591,536, entitled“Ultrasonic Surgical Instrument Blades,” issued Nov. 26, 2013, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.8,623,027, entitled “Ergonomic Surgical Instruments,” issued Jan. 7,2014, the disclosure of which is incorporated by reference herein; U.S.Pat. No. 9,095,367, entitled “Flexible Harmonic Waveguides/Blades forSurgical Instruments,” issued Aug. 4, 2015, the disclosure of which isincorporated by reference herein; and U.S. Pub. No. 2016/0022305,entitled “Ultrasonic Blade Overmold,” published Jan. 28, 2016, issued asU.S. Pat. No. 9,750,521 on Sep. 5, 2017, the disclosure of which isincorporated by reference herein.

An ultrasonic surgical instrument generally includes an ultrasonictransducer and an ultrasonic blade configured to be driven by theultrasonic transducer. Various ultrasonic surgical instruments enablethe ultrasonic blade to be selectively attached and detached from theultrasonic transducer, via a threaded coupling between the twocomponents. It is desirable to apply an appropriate amount of torque tothis threaded coupling when assembling the blade with the transducer.Applying too much torque can cause the threaded coupling to fracture andfail during use, and applying too little torque can cause the threadedcoupling to loosen and inhibit effective transmission of ultrasonicenergy to tissue during use. Either result is undesirable, and canrender the surgical instrument ineffective or entirely inoperable.Ultrasonic blades and transducers of conventional ultrasonic surgicalinstruments may be assembled with a hand-held torque wrench tool that isprovided separately from the surgical instrument. The torque wrench toolincludes features that limit application of additional torque to thethreaded coupling between the ultrasonic blade and transducer once apredetermined amount of torque has been reached. An example of such atorque wrench tool is disclosed in U.S. Pat. No. 5,059,210, entitled“Apparatus and Methods for Attaching and Detaching an UltrasonicActuated Blade/Coupler and an Acoustical Mount Therefor,” issued Oct.22, 1991, the disclosure of which is incorporated by reference herein.

While various types of ultrasonic surgical instruments and torque wrenchmechanisms have been made and used, it is believed that no one prior tothe inventor(s) has made or used the invention described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 depicts a side view of a first exemplary ultrasonic surgicalinstrument having a handle assembly and a shaft assembly with an endeffector;

FIG. 2A depicts an enlarged side view of the end effector of FIG. 1 inan open configuration;

FIG. 2B depicts the enlarged side view of the end effector similar toFIG. 2A, but with the end effector in a closed configuration;

FIG. 3 depicts a partially exploded side view of the ultrasonic surgicalinstrument of FIG. 1;

FIG. 4 depicts a partially schematic enlarged side view of an ultrasonictransducer, a waveguide, and a rotation knob of the ultrasonic surgicalinstrument of FIG. 1, showing attachment of the waveguide to theultrasonic transducer;

FIG. 5 depicts a partially schematic enlarged side view of a threadedcoupling between the ultrasonic transducer and the waveguide of FIG. 4;and

FIG. 6 depicts a partially exploded side view of a second exemplaryultrasonic surgical instrument having a first additive usage indicatorfor a shaft assembly and a handle assembly;

FIG. 7A depicts an enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator of FIG. 6 with theshaft assembly being inserted into the handle assembly;

FIG. 7B depicts the enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator similar to FIG. 7A,but showing the shaft assembly inserted into the handle assembly;

FIG. 7C depicts the enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator similar to FIG. 7B,but having various features hidden for more clearly showing a shaftcoupling in an unlocked state between the shaft assembly and the handleassembly;

FIG. 7D depicts the enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator similar to FIG. 7C,but showing the shaft coupling in a locked state and the shaft assemblyattached to the handle assembly with the first additive usage indicatorindicating a first use of the handle assembly;

FIG. 7E depicts the enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator similar to FIG. 7D,but showing the shaft assembly removed from the handle assembly afteruse and the first additive usage indicator indicating the first use ofthe handle assembly;

FIG. 7F depicts the enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator similar to FIG. 7E,but showing another, replacement shaft assembly being inserted into thehandle assembly;

FIG. 7G depicts the enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator similar to FIG. 7F,but showing the shaft assembly inserted into the handle assembly and thefirst additive usage indicator indicating a second use of the handleassembly;

FIG. 8A depicts an enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator of FIG. 6 indicating acomplete usage of the handle assembly and the shaft assembly beinginserted toward the handle assembly;

FIG. 8B depicts the enlarged top view of the ultrasonic surgicalinstrument and the first additive usage indicator similar to FIG. 8B,but showing the first additive usage indicator inhibiting attachment ofthe shaft assembly to the handle assembly following the complete usageof the handle assembly;

FIG. 9 depicts an enlarged perspective view of a third exemplaryultrasonic surgical instrument having a second additive usage indicatorfor a shaft assembly and a handle assembly;

FIG. 10 depicts an enlarged, partially exploded perspective view of theultrasonic surgical instrument with the second additive usage indicatorof FIG. 9;

FIG. 11 depicts an enlarged perspective view of the handle assembly withthe second additive usage indicator of FIG. 9;

FIG. 12A depicts an enlarged perspective view of the ultrasonic surgicalinstrument and the second additive usage indicator of FIG. 9 with theshaft assembly being inserted into the handle assembly;

FIG. 12B depicts the enlarged perspective view of the ultrasonicsurgical instrument and the second additive usage indicator similar toFIG. 12A, but showing the shaft assembly being connected to the handleassembly and the second additive usage indicator indicating the firstuse of the handle assembly;

FIG. 12C depicts the enlarged perspective view of the ultrasonicsurgical instrument and the second additive usage indicator similar toFIG. 12B, but showing the shaft assembly being removed from the handleassembly after use and the second additive usage indicator indicatingthe first use of the handle assembly;

FIG. 12D depicts the enlarged perspective view of the ultrasonicsurgical instrument and the second additive usage indicator similar toFIG. 12C, but showing another, replacement shaft assembly being insertedinto the handle assembly;

FIG. 12E depicts the enlarged perspective view of the ultrasonicsurgical instrument and the second additive usage indicator similar toFIG. 12D, but showing the replacement shaft assembly being connected tothe handle assembly and the second additive usage indicator indicating asecond use of the handle assembly;

FIG. 13 depicts a perspective view of an enlarged perspective view of afourth exemplary ultrasonic surgical instrument having a first wheelratchet usage indicator for a shaft assembly and a handle assembly;

FIG. 14 depicts an enlarged side view of the ultrasonic surgicalinstrument and the first wheel ratchet usage indicator of FIG. 13 havingvarious components hidden for clarity;

FIG. 15 depicts a perspective view of the first wheel ratchet usageindicator of FIG. 13;

FIG. 16A depicts a perspective view of the first wheel ratchet usageindicator of FIG. 13 actuating from a first usage indication to a secondusage indication;

FIG. 16B depicts the perspective view of the first wheel ratchet usageindicator similar to FIG. 16A, but showing the first wheel ratchet usageindicator indicating the second usage;

FIG. 17 depicts a partially exploded side view of a fifth exemplaryultrasonic surgical instrument having a second wheel ratchet usageindicator for a shaft assembly and a handle assembly;

FIG. 18 depicts an enlarged perspective view of the ultrasonic surgicalinstrument of FIG. 17 with a portion of the shaft assembly beinginserted into the handle assembly;

FIG. 19 depicts an exploded perspective view of the second wheel ratchetusage indicator of FIG. 17;

FIG. 20 depicts an enlarged perspective view of a sixth exemplaryultrasonic surgical instrument having a third wheel ratchet usageindicator for a shaft assembly and a handle assembly;

FIG. 21 depicts a partially exploded, enlarged perspective view of theultrasonic surgical instrument of FIG. 20;

FIG. 22 depicts a perspective view of a ratchet wheel of the third wheelratchet usage indicator of FIG. 20;

FIG. 23A depicts a perspective view of a ratchet mechanism of the thirdwheel ratchet usage indicator of FIG. 20 with the ratchet mechanism in acontracted state;

FIG. 23B depicts the perspective view of the ratchet mechanism similarto FIG. 23A, but showing the ratchet mechanism in an expanded state;

FIG. 24A depicts an enlarged distal end view of the ultrasonic surgicalinstrument of FIG. 20 with the ratchet mechanism of FIG. 23A in thecontracted state;

FIG. 24B depicts the enlarged distal end view of the ultrasonic surgicalinstrument similar to FIG. 24A, but showing the ratchet mechanism ofFIG. 23B in the expanded state;

FIG. 25A depicts an enlarged top view of the ultrasonic surgicalinstrument and the third wheel ratchet usage indicator of FIG. 20 withvarious features hidden for clarity;

FIG. 25B depicts the enlarged top view of the ultrasonic surgicalinstrument and the third wheel ratchet usage indicator similar to FIG.25A, but showing the shaft assembly being inserted into the handleassembly and the ratchet mechanism urging the ratchet wheel to indicatea second usage;

FIG. 25C depicts the enlarged top view of the ultrasonic surgicalinstrument and the third wheel ratchet usage indicator similar to FIG.25B, but showing the shaft assembly being removed from the handleassembly after use and the third wheel ratchet usage indicatorindicating the second use of the handle assembly;

FIG. 26 depicts an enlarged perspective view of a seventh exemplaryultrasonic surgical instrument having a fourth wheel ratchet usageindicator for a shaft assembly and a handle assembly;

FIG. 27 depicts a perspective view of the fourth wheel ratchet usageindicator of FIG. 26;

FIG. 28A depicts an enlarged perspective view of the ultrasonic surgicalinstrument and the fourth wheel ratchet usage indicator of FIG. 26 withthe shaft assembly being inserted into the handle assembly, anultrasonic transducer withdrawn to a proximal position, and variousfeatures hidden for clarity;

FIG. 28B depicts the enlarged perspective view of the ultrasonicsurgical instrument and the fourth wheel ratchet usage indicator similarto FIG. 28A, but showing a waveguide being introduced into theultrasonic transducer in the proximal position;

FIG. 28C depicts the enlarged perspective view of the ultrasonicsurgical instrument and the fourth wheel ratchet usage indicator similarto FIG. 28B, but showing the waveguide being threadably coupled with theultrasonic transducer thereby pulling the ultrasonic transducer distallyfrom the proximal position toward a distal position and urging thefourth wheel ratchet usage indicator to indicate a second usage;

FIG. 29 depicts an enlarged perspective view of an eighth exemplaryultrasonic surgical instrument having a fifth wheel ratchet usageindicator for a shaft assembly and a handle assembly;

FIG. 30 depicts a side view of the fifth wheel ratchet usage indicatorof FIG. 29;

FIG. 31A depicts an enlarged side view of the ultrasonic surgicalinstrument and the fifth wheel ratchet usage indicator of FIG. 29 havingvarious features hidden for more clearly showing the fifth wheel ratchetusage indicator within the handle assembly;

FIG. 31B depicts the enlarged side view of the ultrasonic surgicalinstrument and the fifth wheel ratchet usage indicator similar to FIG.31A, but showing the shaft assembly connected to the handle assembly andurging the fifth wheel ratchet usage indicator to indicate a secondusage;

FIG. 32A depicts a side view of a linear ratchet usage indicator havinga ratchet mechanism and a linear ratchet indicating a third usage with ashaft assembly;

FIG. 32B depicts the side view of the linear ratchet usage indicatorsimilar to FIG. 32A, but showing the ratchet mechanism biased to adistal position upon removal of the shaft assembly;

FIG. 32C depicts the side view of the linear ratchet usage indicatorsimilar to FIG. 32B, but showing the ratchet mechanism being urgedproximally to a proximal position by the shaft assembly to thereby urgethe linear ratchet to indicate a fourth usage with the shaft assembly;

FIG. 33 depicts an enlarged perspective view of a ninth exemplaryultrasonic surgical instrument having a slip ratchet usage indicator fora shaft assembly and a handle assembly;

FIG. 34 depicts an enlarged, partially exploded perspective view of theultrasonic surgical instrument and the slip ratchet usage indicator ofFIG. 33;

FIG. 35A depicts a cross-sectional view of the ultrasonic surgicalinstrument and the slip ratchet usage indicator taken along section line35A-35A of FIG. 34 with the shaft assembly removed from the handleassembly and the slip ratchet usage indicator indicating a first usage;

FIG. 35B depicts the cross-sectional view of the ultrasonic surgicalinstrument and the slip ratchet usage indicator similar to FIG. 35A, butshowing the shaft assembly inserted into the handle assembly in anunlocked state;

FIG. 35C depicts the cross-sectional view of the ultrasonic surgicalinstrument and the slip ratchet usage indicator similar to FIG. 35B, butshowing the shaft assembly being rotated from the unlocked state towardthe locked state to thereby rotate the slip ratchet usage indicator;

FIG. 35D depicts the cross-sectional view of the ultrasonic surgicalinstrument and the slip ratchet usage indicator similar to FIG. 35C, butshowing the shaft assembly in the locked state and the slip ratchetusage indicator indicating a second usage;

FIG. 35E depicts the cross-sectional view of the ultrasonic surgicalinstrument and the slip ratchet usage indicator similar to FIG. 35D, butshowing the shaft assembly being rotated from the locked state towardthe unlocked state for removal after use and the slip ratchet usageindicator indicating the second usage;

FIG. 36 depicts an enlarged perspective view of a tenth exemplaryultrasonic surgical instrument having a cycle response usage indicatorfor a shaft assembly and a handle assembly;

FIG. 37 depicts a perspective view of the cycle response usage indicatorof FIG. 36;

FIG. 38 depicts a distal end view of a ratchet actuator of the cycleresponse usage indicator of FIG. 37 with the ratchet actuator in anunactuated state;

FIG. 39 depicts a distal end view of the ratchet actuator of FIG. 38with the ratchet actuator in an actuated state;

FIG. 40A depicts a cross-sectional view of the ultrasonic surgicalinstrument and the cycle response usage indicator taken along sectionline 40A-40A of FIG. 36 with the ratchet actuator in the unactuatedstate and indicating a first usage;

FIG. 40B depicts the cross-sectional view of the ultrasonic surgicalinstrument and the cycle response usage indicator similar to FIG. 40A,but showing the ratchet actuator actuating from the unactuated statetoward the actuated state such that the cycle response usage indicatorrotates toward an indication of a second usage;

FIG. 40C depicts the cross-sectional view of the ultrasonic surgicalinstrument and the cycle response usage indicator similar to FIG. 40B,but showing the ratchet actuator in the actuated state such that thecycle response usage indicator indicates the second usage;

FIG. 40D depicts the cross-sectional view of the ultrasonic surgicalinstrument and the cycle response usage indicator similar to FIG. 40B,but showing the ratchet actuator returned from the actuated state to theunactuated state such that the cycle response usage indicator continuesto indicate the second usage;

FIG. 41 depicts an enlarged side view of an eleventh exemplaryultrasonic surgical instrument having a first circuit usage indicatorfor a shaft assembly and a handle assembly;

FIG. 42 depicts a side view of a circuit board of the first circuitusage indicator of FIG. 41 having a plurality of use tabs;

FIG. 43 depicts a side view of the circuit board of FIG. 42 with theplurality of use tabs hidden for greater clarity;

FIG. 44A depicts an enlarged perspective view of the circuit board ofFIG. 42 with a first numeral usage tab in a use remaining positionindicating a first usage is in use;

FIG. 44B depicts the enlarged perspective view of the circuit boardsimilar to FIG. 44A, but with the first use tab in a used positionindicating the first usage is used;

FIG. 45A depicts a sectional view of the circuit board taken along acenterline of the first use tab in the use remaining position of FIG.44A showing a closed-circuit portion;

FIG. 45B depicts a sectional view of the circuit board taken along acenterline of the first use tab in the used position of FIG. 44B showingan opened circuit portion;

FIG. 46A depicts an enlarged perspective view of a second circuit usageindicator having a circuit board with a first use tab in a use remainingposition indicating a first usage is in use;

FIG. 46B depicts the enlarged perspective view of the circuit boardsimilar to FIG. 46A, but with the first use tab removed therebyindicating the first usage is used;

FIG. 47 depicts a perspective view of the first numeral usage tab ofFIG. 46A;

FIG. 48A depicts an enlarged perspective view of a twelfth exemplaryultrasonic surgical instrument having first a switch usage indicator fora shaft assembly and a handle assembly with the first switch usageindicator in a use remaining position;

FIG. 48B depicts the enlarged perspective view of the ultrasonicsurgical instrument and the first switch usage indicator similar to FIG.48A, but showing the first switch usage indicator in a used position;

FIG. 49A depicts a side view of the ultrasonic surgical instrument andthe first switch usage indicator of FIG. 48A having various featuresremoved for more clearly showing the first switch usage indicator in theuse remaining position;

FIG. 49B depicts a side view of the ultrasonic surgical instrument andthe first switch usage indicator of FIG. 48B having various featuresremoved for more clearly showing the first switch usage indicator in theused position;

FIG. 50A depicts an enlarged side view of a thirteenth exemplaryultrasonic surgical instrument having various features hidden for moreclearly showing a second switch usage indicator for a shaft assembly anda handle assembly with the second switch usage indicator in a useremaining position; and

FIG. 50B depicts the enlarged side view of the ultrasonic surgicalinstrument and the second switch usage indicator similar FIG. 50A, butshowing the second switch usage indicator in a used position.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

For clarity of disclosure, the terms “proximal” and “distal” are definedherein relative to a surgeon, or other operator, grasping a surgicalinstrument having a distal surgical end effector. The term “proximal”refers to the position of an element arranged closer to the surgeon, andthe term “distal” refers to the position of an element arranged closerto the surgical end effector of the surgical instrument and further awayfrom the surgeon. Moreover, to the extent that spatial terms such as“upper,” “lower,” “vertical,” “horizontal,” or the like are used hereinwith reference to the drawings, it will be appreciated that such termsare used for exemplary description purposes only and are not intended tobe limiting or absolute. In that regard, it will be understood thatsurgical instruments such as those disclosed herein may be used in avariety of orientations and positions not limited to those shown anddescribed herein.

I. Exemplary Surgical Instrument

FIGS. 1-2B show an exemplary ultrasonic surgical instrument (10) thatincludes a handle assembly (12), a shaft assembly (14) extendingdistally from handle assembly (12), and an end effector (16) arranged ata distal end of shaft assembly (14). Handle assembly (12) comprises abody (18) including a pistol grip (20) and energy control buttons (22)configured to be manipulated by a surgeon to control various aspects oftissue treatment energy delivered by surgical instrument (10). A trigger(24) is coupled to a lower portion of body (18) and is pivotable towardand away from pistol grip (20) to selectively actuate end effector (16).In other suitable variations of surgical instrument (10), handleassembly (12) may comprise a scissor grip configuration, for example.Body (18) houses an ultrasonic transducer (20, shown schematically inFIG. 1, configured to deliver ultrasonic energy to end effector (16), asdescribed in greater detail below. Body (18) may also be referred toherein as a housing (18) and may include one component or an assembly ofcomponents. The terms “body” and “housing” are thus not intended tounnecessarily limit the invention described herein to any number ofdiscrete components.

As shown best in FIGS. 2A-2B, end effector (16) includes an ultrasonicblade (28) and a clamp arm (30) configured to selectively pivot towardand away from ultrasonic blade (28) for clamping tissue therebetween.Clamp arm (30) includes a clamp pad (32) arranged on a clamping sidethereof and is moveable from an open position shown in FIG. 2A to aclosed position shown in FIG. 2B. With respect to FIG. 3, ultrasonicblade (28) is acoustically coupled with ultrasonic transducer (26),which is configured to drive (i.e., vibrate) ultrasonic blade (28) atultrasonic frequencies for cutting and/or sealing tissue positioned incontact with ultrasonic blade (28). Clamp arm (30) is operativelycoupled with trigger (24) such that clamp arm (30) is configured topivot toward ultrasonic blade (28), to the closed position, in responseto pivoting of trigger (24) toward pistol grip (20). Further, clamp arm(30) is configured to pivot away from ultrasonic blade (28), to the openposition in response to pivoting of trigger (24) away from pistol grip(20). Various suitable ways in which clamp arm (30) may be coupled withtrigger (24) will be apparent to those of ordinary skill in the art inview of the teachings provided herein. In some versions, one or moreresilient members may be incorporated to bias clamp arm (30) and/ortrigger (24) toward the open position.

Shaft assembly (14) of the present example extends along a longitudinalaxis and includes an outer tube (34), an inner tube (36) received withinouter tube (34), and an ultrasonic waveguide (38) supported within andextending longitudinally through inner tube (36). Ultrasonic blade (28)is formed integrally with and extends distally from waveguide (38). Aproximal end of clamp arm (30) is pivotally coupled to distal ends ofouter and inner tubes (34, 36), enabling clamp arm (30) to pivotrelative to shaft assembly (14) about a pivot axis defined by a pivotpin (40) (see FIG. 2A) extending transversely through the distal end ofinner tube (36).

In the present example, inner tube (36) is longitudinally fixed relativeto handle assembly (18), and outer tube (34) is configured to translaterelative to inner tube (36) and handle assembly (18), along thelongitudinal axis of shaft assembly (20). As outer tube (34) translatesdistally, clamp arm (30) pivots about its pivot axis toward its openposition. As outer tube (34) translates proximally, clamp arm (30)pivots about its pivot axis in an opposite direction toward its closedposition. Though not shown, a proximal end of outer tube (34) isoperatively coupled with trigger (24) such that actuation of trigger(24) causes translation of outer tube (34) relative to inner tube (36),thereby opening or closing clamp arm (30) as discussed above. In othersuitable configurations not shown herein, outer tube (34) may belongitudinally fixed and inner tube (36) may be configured to translatefor moving clamp arm (30) between the open and closed positions. Variousother suitable mechanisms for actuating clamp arm (30) between the openand closed positions will be apparent to those of ordinary skill in theart.

Shaft assembly (14) and end effector (16) are configured to rotatetogether relative to body (18) about the longitudinal axis defined byshaft assembly (14). As shown in FIGS. 3-4, shaft assembly (14) furtherincludes a rotation knob (42) arranged at a proximal end thereof.Rotation knob (42) is rotatably coupled to body (18) of handle assembly(12), and is rotationally fixed to outer tube (34), inner tube (36), andwaveguide (38) by a coupling pin (not shown) extending transverselytherethrough. Coupling pin (not shown) is arranged at a longitudinallocation corresponding to an acoustic node of waveguide (38). In otherexamples, rotation knob (42) may be rotationally fixed to the remainingcomponents of shaft assembly (14) in various other manners. Rotationknob (42) is configured to be gripped by a user to selectivelymanipulate the rotational orientation of shaft assembly (14) and endeffector (16) relative to handle assembly (12). Various examples ofacoustic and mechanical connections between shaft assembly (14) andhandle assembly (14) are described in greater detail in U.S. patentapplication Ser. No. 15/644,930, entitled “Acoustic Drivetrain withExternal Collar at Nodal Position,” filed on Jul. 10, 2017, published asU.S. Pub. No. 2019/0008546 on Jan. 10, 2019, and U.S. patent applicationSer. No. 15/644,944, entitled “Features to Couple Acoustic DrivetrainComponents in Ultrasonic Surgical Instrument,” filed on Jul. 10, 2017,published as U.S. Pub. No. 2019/0008547 on Jan. 10, 2019, thedisclosures of which are each incorporated by reference herein.

FIGS. 3-5 show additional details of ultrasonic transducer (26) andwaveguide (38). In particular, ultrasonic transducer (26) and waveguide(38) are configured to threadedly couple together. Accordingly,waveguide (38) is configured to acoustically couple ultrasonictransducer (26) with ultrasonic blade (28), and thereby communicateultrasonic mechanical vibrations from ultrasonic transducer (26) toblade (28). In this manner, ultrasonic transducer (26), waveguide (38),and ultrasonic blade (28) together define an acoustic assembly ofultrasonic surgical instrument (10). Ultrasonic transducer (26) isrotatably supported within body (18) of handle assembly (12), and isconfigured to rotate with shaft assembly (14), including waveguide (38),and end effector (16) about the longitudinal axis of shaft assembly(14).

Ultrasonic transducer (26) is electrically coupled with a generator (notshown), which may be provided externally of ultrasonic surgicalinstrument (10) or integrated within surgical instrument (10). Duringuse, generator (not shown) powers ultrasonic transducer (26) to produceultrasonic mechanical vibrations, which are communicated distallythrough waveguide (38) to ultrasonic blade (28). Ultrasonic blade (28)is caused to oscillate longitudinally in the range of approximately 10to 500 microns peak-to-peak, for example, and in some instances in therange of approximately 20 to 200 microns, at a predetermined vibratoryfrequency f_(o) of approximately 50 kHz, for example. Vibratingultrasonic blade (28) may be positioned in direct contact with tissue,with or without assistive clamping force provided by clamp arm (30), toimpart ultrasonic vibrational energy to the tissue and thereby cutand/or seal the tissue. For example, blade (28) may cut through tissueclamped between clamp arm (30) and a clamping side of blade (28), orblade (28) may cut through tissue positioned in contact with anoppositely disposed non-clamping side of blade (28) having an edge, forexample during a “back-cutting” movement. In some versions, waveguide(38) may be configured to amplify the ultrasonic vibrations delivered toblade (28). Waveguide (38) may include various features operable tocontrol the gain of the vibrations, and/or features suitable to tunewaveguide (38) to a selected resonant frequency.

In the present example, ultrasonic transducer (26) includes a firstresonator (or “end-bell”) (48), a conically shaped second resonator (or“fore-bell”) (50), and a transduction portion arranged between end-bell(48) and fore-bell (50) that includes a plurality of piezoelectricelements (52). A compression bolt (not shown) extends distally,coaxially through end-bell (48) and piezoelectric elements (52), and isthreadedly received within a proximal end of fore-bell (50). A velocitytransformer (or “horn”) (54) extends distally from fore-bell (146) andincludes an internally threaded bore (56) configured to receive andthreadedly couple with an externally threaded proximal tip (58) ofwaveguide (38) as shown in FIGS. 4-5.

While the teachings herein are disclosed in connection with ultrasonicsurgical instruments, it will be appreciated that they may also beemployed in connection with surgical instruments configured to provide acombination of ultrasonic and radio frequency (RF) energies. Examples ofsuch instruments and related methods and concepts are disclosed in U.S.Pat. No. 8,663,220, entitled “Ultrasonic Surgical Instruments,” issuedMar. 4, 2014, the disclosure of which is incorporated by referenceherein; U.S. Pub. No. 2015/0141981, entitled “Ultrasonic SurgicalInstrument with Electrosurgical Feature,” published May 21, 2015, issuedin U.S. Pat. No. 9,949,785 on Apr. 24, 2018, the disclosure of which isincorporated by reference herein; and U.S. Pub. No. 2017/0000541,entitled “Surgical Instrument with User Adaptable Techniques,” publishedJan. 5, 2017, the disclosure of which is incorporated by referenceherein.

II. Various Integrated Usage Indicators

Given that various portions of ultrasonic surgical instrument (10)removably connect together, it may be desirable in various examples toreuse some portions of ultrasonic surgical instrument (10) whilereplacing others upon reconnection for further use by the surgeon. Forexample, handle assembly (12) in the present example is reusable whereasshaft assembly (14) may be disconnected and replaced with an unused,replacement shaft assembly (14). Despite the reusability of handleassembly (12), one or more components of handle assembly (12) may bereplaced after a predetermined number of use cycles of use for eachrespective patient treatment. For example, ultrasonic transducer (26)may operate efficiently and effectively up to five use cycles, butperformance may deteriorate beyond the five use cycles such thatreplacement of handle assembly (12) is desirable.

While such reuse of handle assembly (12) followed by replacement ofhandle assembly (12) may be desirable, inhibiting reuse beyond thepredetermined number of use cycles may be complicated, difficult, ortedious given that inspection of handle assembly (12) may not readilycommunicate the predetermined complete usage of handle assembly (12). Anintegrated usage indicator (116, 216, 316, 416, 516, 716, 816, 916,1016, 1116, 1216, 1316, 1416) with a used state indicator as describedbelow may thus be desirable in some instance for indicating usage to aclinician, such as the surgeon, without the need for manually trackingsuch usage separate from handle assembly (12). Once used state indicatorindicates such use in a used state to the clinician, a replacementhandle assembly (12) may be used for a following patient treatment.While various examples are given below regarding a particular number ofuses and/or reuses, it will be appreciated that any number of usesand/or reuses may be possible in other examples. The invention is thusnot intended to be unnecessarily limited to a particular number of usesand/or reuses.

The following description provides various examples of integrated usageindicators (116, 216, 316, 416, 516, 716, 816, 916, 1016, 1116, 1216,1316, 1416). Such integrated usage indicators (116, 216, 316, 416, 516,716, 816, 916, 1016, 1116, 1216, 1316, 1416) described below may be usedwith any ultrasonic surgical instrument described above and below and inany of the various procedures described in the various patent referencescited herein. To this end, like numbers below indicated like featuresdescribed above. Other suitable ways in which various ultrasonicsurgical instruments may be used will be apparent to those of ordinaryskill in the art in view of the teachings herein.

A. First Additive Usage Indicator

FIGS. 6-8B illustrate a second exemplary ultrasonic surgical instrument(110) having a handle assembly (112) configured to be operated up to apredetermined number of use cycles, a shaft assembly (114) configuredfor a single use cycle of treatment, and a first additive usageindicator (116). With respect to FIGS. 6-7A, first additive usageindicator (116) is integrated into portions of shaft assembly (114) anda housing (118) of handle assembly (112) for recording and indicatingeach respective use cycle of handle assembly (112) in a use remainingstate to a used state. First additive usage indicator (116) has a shaftportion (119) that cooperates with a housing portion (120) uponconnection of shaft assembly (114) to handle assembly (112) to therebydirect first additive usage indicator (116) toward the used state witheach replacement shaft assembly (114). Once shaft assembly (114) hasbeen replaced the predetermined number of use cycles, first additiveusage indicator (116) indicates the used state of handle assembly (112)to the clinician. Such indication of first additive usage indicator(116) is visual as well as a lockout, which inhibits operation of handleassembly (112).

As shown in FIG. 7A, shaft portion (119) of first additive usageindicator (116) includes an annular collar body (122) position on aproximal end portion of shaft assembly (114) about outer tube (34). Aplurality of stop members (124) are angularly positioned about theannular collar (122) and extend radially outward therefrom. In addition,a counter ring member (126) is translatably positioned on annular collarbody (122) against a proximal surface of stop members (124). Thereby,stop members (124) inhibit distal movement of counter ring member (126)relative to annular collar body (122), but allow proximal movement ofcounter ring member (126) relative to annular collar body (122) untildetached therefrom.

Housing portion (120) of first additive usage indicator (116) includes acapture knob (142) having a longitudinally extending indicia window(128) and a catch (130) having a pair of laterally positioned andlongitudinally cantilevered catch arms (132) about a catch post (134).Capture knob (142) operates similar to knob (42) (see FIG. 2) oncereceiving outer tube (34) for treatment, but is a portion of housing(118) rather than shaft assembly (114). As the proximal portion of shaftassembly (114) is inserted into handle assembly (112) for mechanical andacoustic connection therewith, catch post (134) axially receives counterring member (126) thereon. In addition, catch arms (132) bias radiallyoutward to receive counter ring member (126) between and capture counterring member (126) on catch post (134) as shown in FIG. 7B. Each capturearm (132) of the present example further includes a plurality of innerratchet teeth (136) configured to inhibit distal movement of counterring member (126) relative to capture knob (142), but allow proximalmovement of counter ring member (126) relative to capture knob (142). Inthis respect, proximal movement of stop members (124) urge counter ringmember (126) onto catch post (134) for capture by catch arms (132) untilbayonet slot (138) receives bayonet pin (140) for mechanically couplingshaft assembly (114) to handle assembly (112) as shown in FIGS. 7C-7D.

As briefly discussed above, capture knob (142) includes indicia window(128) through catch post (134) for clinician to visually identify thepresence of any counter ring members (126) received on catch post (134).In addition, catch post (132) further includes a series of counterindices (144), which are longitudinally and linearly positioned oncapture knob (142) increasing in the proximal direction. The presentexample of counter indices (144) includes proximally increasing numbers“1,” “2,” “3,” “4,” and “5” and are respectively configured tocorrespond to each replacement shaft assembly (114) used with handleassembly (112) in relation to counter ring members (126). For example,as shown in FIGS. 7D-7E, a first counter ring member (126)longitudinally aligns with counter indicia (144) “1” to indicate to theclinician through indicia window (128) that handle assembly (112) is inits first use.

Given that catch arms (132) are configured to capture counter ringmember (126), removal of shaft assembly (114) from handle assembly (112)causes capture ring member (126) to remain with capture knob (142). Withrespect to FIGS. 7F-7G, additional replacement shaft assemblies (114)with respective counter ring members (126) used with handle assembly(112) simply urge each captured counter ring member (126) proximally toalign with the successive counter indicia (144). Thus, even afterremoval of one or more shaft assemblies (114) from handle assembly(112), the number of use cycles based shaft assembly connections (114)is recorded with handle assembly (112) throughout the remaining usestate. In one example, counter ring members (126) may in addition oralternatively include a radio-frequency identification (RFID) tag forrecording uses.

Once catch (130) is full of counter ring members (126), first additiveusage indicator is visually in the used state as shown in FIGS. 8A-8B.In addition, catch (130) is configured to receive no more counter ringmembers (126) than those that correspond to the predetermined number ofuse cycles based on replacement shaft assemblies (114). An additionalcounter ring member (126) greater than the predetermined number of usecycles, which in the present example is five, is configured to blockacoustic and mechanical connection of another replacement shaft assembly(114) to handle assembly. First additive usage indicator (116) isthereby configured to inhibit inadvertently using handle assembly (112)beyond the predetermined number of use cycles.

In use, with respect to FIGS. 7A-7G, the clinician connects the firstreplacement shaft assembly (114) to handle assembly (112) such thatcounter ring member (126) is captured by catch (130) in alignment withthe first indicia (144) for indicating the first use to clinician.Following treatment of the patient, shaft assembly (114) is disconnectedfrom handle assembly (112) thereby detaching counter ring member (126)from shaft assembly (114). Handle assembly (112) is then prepped, suchas by heating and/or sterilizing, for another surgical procedure andanother replacement shaft assembly (114) is connected to handle assembly(112). The second counter ring member (126) urges the first counter ringmember (126) in alignment with the second indicia for indicating thesecond use to the clinician. Such reuse continues as shown in FIGS.7A-7G in the remaining use state until catch (130) is full of counterring members (126) in the used state as shown in FIGS. 8A-8G.

B. Second Additive Usage Indicator

FIGS. 9-12E illustrate a third exemplary ultrasonic surgical instrument(210) having a handle assembly (212) configured to be operated up to apredetermined number of use cycles, a shaft assembly (214) configuredfor a single use cycle of treatment, and a second additive usageindicator (216). With respect to FIGS. 9-10, second additive usageindicator (216) is integrated into portions of shaft assembly (214) anda housing (218) of handle assembly (212) for recording and indicatingeach respective use cycle of handle assembly (212) in a use remainingstate to a used state. Second additive usage indicator (216) has a shaftportion (219) that cooperates with a housing portion (220) uponconnection of shaft assembly (214) to handle assembly (212) to therebydirect second additive usage indicator (216) toward the used state witheach replacement shaft assembly (214). Once shaft assembly (214) hasbeen replaced the predetermined number of use cycles, second additiveusage indicator (216) indicates the used state of handle assembly (212)to the clinician. Such indication of second additive usage indicator(216) is visual as well as a lockout, which inhibits operation of handleassembly (212).

As shown in FIG. 10, shaft portion (219) of first additive usageindicator (216) includes a detachable counter tab member (226)projecting proximally knob (42). Counter tab member (226) is moreparticularly frangible connected to shaft assembly (214) such thatapplying a shear force to counter tab member (226) breaks counter tabmember (226) therefrom. Housing portion (220) of second additive usageindicator (216) includes longitudinally extending indicia window (228)into a catch (230) having a longitudinally extending catch tab slot(232). As the proximal portion of shaft assembly (214) is inserted intohandle assembly (112) for mechanical and acoustic connection therewith,counter tab member (226) is inserted into a distal opening (not shown)of catch tab slot (232) as shown in FIGS. 11-12A. Catch tab slot (232)includes a plurality of inner ratchet teeth (236) configured to inhibitdistal movement of counter tab member (226) relative to housing (218),but allow proximal movement of counter tab member (226) relative tohousing (218). In this respect, proximal movement of shaft assembly(214) urges counter tab member (226) into catch tab slot (232) forcapture by inner ratchet teeth (236) until bayonet slot (138) (see FIG.7C) receives bayonet pin (140) (see FIG. 7C) for mechanically couplingshaft assembly (214) to handle assembly (212). Rotating shaft assembly(214) for such connection with counter tab member (226) simultaneouslycaptured within catch tab slot (232) breaks counter tab member (226)from shaft assembly (2214) to be retained within catch tab slot (232) asdiscussed below in greater detail.

As briefly discussed above, indicia window (228) into catch tab slot(232) provides clinician with visual identification of the presence ofany counter tab members (226) received therein. In addition, housing(218) further includes a series of counter indices (244), which arelongitudinally and linearly positioned on housing (244) increasing inthe proximal direction. The present example of counter indices (244)includes proximally increasing numbers “1,” “2,” “3,” “4,” and “5” andare respectively configured to correspond to each replacement shaftassembly (214) used with handle assembly (212) in relation to countertab members (226). For example, as shown in FIG. 12B, a first countertab member (226) longitudinally aligns with counter indicia (244) “1” toindicate to the clinician through indicia window (228) that handleassembly (212) is in its first use.

Given that inner ratchet teeth (232) are configured to capture countertab member (226), capture tab member (226) remains within catch (230)upon removal of shaft assembly (214) from handle assembly (212). Withrespect to FIGS. 12D-12E, additional replacement shaft assemblies (214)with respective counter tab members (226) used with handle assembly(212) simply urge each captured counter tab member (226) proximally toalign with the successive counter indicia (244). Thus, even afterremoval of one or more shaft assemblies (214) from handle assembly(212), the number of use cycles based shaft assembly connections (214)is recorded with handle assembly (212) throughout the remaining usestate. In one example, counter tab members (226) may in addition oralternatively include a radio-frequency identification (RFID) tag forrecording uses.

Once catch (230) is full of counter ring members (226), first additiveusage indicator is visually in the used state. In addition, catch (230)is configured to receive no more counter tab members (226) than thosethat correspond to the predetermined number of use cycles based onreplacement shaft assemblies (214). An additional counter tab member(226) greater than the predetermined number of use cycles, which in thepresent example is five, is configured to block acoustic and mechanicalconnection of another replacement shaft assembly (214) to handleassembly. First additive usage indicator (216) is thereby configured toinhibit inadvertently using handle assembly (212) beyond thepredetermined number of use cycles.

In use, with respect to FIGS. 12A-12G, the clinician connects the firstreplacement shaft assembly (214) to handle assembly (212) such thatcounter tab member (226) is captured by catch (230) in alignment withthe first indicia (244) for indicating the first use to clinician.Following treatment of the patient, shaft assembly (214) is disconnectedfrom handle assembly (212) thereby detaching counter tab member (226)from shaft assembly (214). Handle assembly (212) is then prepped, suchas by heating and/or sterilizing, for another surgical procedure andanother replacement shaft assembly (214) is connected to handle assembly(212). The second counter tab member (226) urges the first counter tabmember (226) in alignment with the second indicia for indicating thesecond use to the clinician. Such reuse continues as shown in FIGS.12A-12G in the remaining use state until catch (230) is full of countertab members (226) in the used state.

C. First Wheel Ratchet Usage Indicator

FIGS. 13-16B illustrate a fourth exemplary ultrasonic surgicalinstrument (310) having a handle assembly (312) configured to beoperated up to a predetermined number of use cycles, a shaft assembly(314) configured for a single use cycle of treatment, and a first wheelratchet usage indicator (316). With respect to FIGS. 13-14, first wheelratchet usage indicator (316) is integrated into portions of shaftassembly (314) and a housing (318) of handle assembly (312) forrecording and indicating each respective use cycle of handle assembly(312) in a use remaining state to a used state. First wheel ratchetusage indicator (316) has a shaft portion (319) that cooperates with ahousing portion (320) upon connection of shaft assembly (314) to handleassembly (312) to thereby direct first wheel ratchet usage indicator(316) toward the used state with each replacement shaft assembly (314).Once shaft assembly (314) has been replaced the predetermined number ofuse cycles, first wheel ratchet usage indicator (316) indicates the usedstate of handle assembly (312) to the clinician. Such indication offirst wheel ratchet usage indicator (316) is visual as well as alockout, which inhibits operation of handle assembly (312).

As shown in FIGS. 14-15, shaft portion (319) of first wheel ratchetusage indicator (316) includes an actuator (322) extending proximallyfrom outer tube (34) toward housing portion (320). Housing portion (320)of first wheel ratchet usage indicator (316) includes a distal housingmount (324), a proximal housing mount (326), and a clutch arrangement(328) mounted therebetween. Clutch arrangement (328) more particularlyincludes a ratchet base (330) with a plurality of base ratchet teeth(332) fixed relative to proximal housing mount (326), a biasing element,such as a compressed coil spring (334), and a wheel ratchet (336). Wheelratchet (336) is rotatably mounted about the longitudinal axis and has aplurality of slip ratchet teeth (338). Wheel ratchet (336) is thusconfigured to indicate usage through an indicia window (340) extendingthrough an upper surface of housing (318) as discussed below in greaterdetail. Compressed coil spring (334) is longitudinally captured betweenwheel ratchet (336) and distal housing mount (326) and thereby biasesslip ratchet teeth (338) of wheel ratchet (336) against base ratchetteeth (332) of ratchet base (330).

Wheel ratchet (336) and ratchet base (330) are generally cylindrical andcoaxially aligned along the longitudinal axis such that slip ratchetteeth (338) and base ratchet teeth (332) are angularly positioned aboutthe longitudinal axis. Each of coil spring (334), ratchet base (330),and wheel ratchet (336) further includes a longitudinally extending holetherethrough configured to receive waveguide (38) for connection withinultrasonic transducer (26). With respect to FIG. 15, engagement betweenslip ratchet teeth (338) and base ratchet teeth (332) as coil spring(334) proximally urges wheel ratchet (336) toward ratchet base (33) andcreates a camming effect that causes slip ratchet teeth (338) to rotateclockwise against base ratchet teeth (332) until effectively lockedthereagainst. Ratchet base (330) thus inhibits further clockwiserotation of wheel ratchet (336). In contrast, forced counterclockwiserotation of wheel ratchet (336) that overcomes the camming effect fromcoil spring (334) provides for further counterclockwise rotation andratcheting of wheel ratchet (336) relative to ratchet base (330) asdiscussed below in greater detail. In the present example, “clockwise”and “counterclockwise” refer to rotation of wheel ratchet (336) asviewed from a distal end of clutch arrangement (328).

In the present example, shaft assembly (314) mechanically andacoustically couples to handle assembly (312) by rotation similar toshaft and handle assemblies (114, 112) (see FIG. 7D). Insertion of outertube (34) into housing (318) engages actuator (322) with an innerportion of wheel ratchet (336) as shown in FIG. 15. For connection ofshaft assembly (314), rotating outer tube (34) counterclockwisesimilarly rotates actuator (322) about the longitudinal axis whileengaged with wheel ratchet (336). Wheel ratchet (336) therebysimultaneously rotates counterclockwise for each connection of areplacement shaft assembly (314) from handle assembly (312). However,because ratchet base (330) locks clockwise movement wheel ratchet (336),the clockwise connection of shaft assembly (314) from handle assembly(312) does not affect the angular position of wheel ratchet (336). Theangular position of wheel ratchet (336) is thus configured to indicateto the clinician the use remaining state as it is rotated in thecounterclockwise direction toward the used state by successiveconnections of replacement shaft assemblies (314).

As briefly discussed above, indicia window (340) (see FIG. 14) providesclinician with visual identification of the angular position of wheelratchet (336). The relative angular position is recorded by a series ofcounter indices (344), which are angularly positioned about wheelratchet (336) and increasing in the clockwise direction. The presentexample of counter indices (344) includes clockwise increasing numbers“1,” “2,” “3,” “4,” and “5” and are respectively configured tocorrespond to each replacement shaft assembly (314) used with handleassembly (312) in relation to the rotational position of wheel ratchet(336). For example, as shown in FIGS. 14-15, a first counter indicia(344) “1” transversely aligns through indicia window (340) to indicateto the clinician that handle assembly (312) is in its first use.

Successive connections of replacement shaft assemblies (314) continue torotate wheel ratchet (336) until a fifth counter indicia (344) “5”transversely aligns through indicia window (340) to visually indicatethe used state of handle assembly (312). In addition, clutch arrangement(328) is configured to mechanically inhibit further connection ofreplacement shaft assemblies (314) greater than the predetermined numberof use cycles. More particularly, wheel ratchet (336) and ratchet base(330) have cooperating blockers (not shown) that longitudinally overlapand engage once wheel ratchet (336) is in the used state to inhibitfurther use. First wheel ratchet usage indicator (316) is therebyconfigured to inhibit inadvertently using handle assembly (312) beyondthe predetermined number of use cycles.

In use, with respect to FIGS. 14-16B, the clinician disconnects firstreplacement shaft assembly (314) from handle assembly (312) such thatactuator (322) urges wheel ratchet (336) with the camming effectcounterclockwise in alignment with the first indicia (344) forindicating the first use to clinician. Handle assembly (312) is thenprepped, such as by heating and/or sterilizing, for another surgicalprocedure and another replacement shaft assembly (314) is connected tohandle assembly (312). Such reuse continues as shown in FIGS. 16A-16B inthe remaining use state until blockers (not shown) on wheel ratchet(336) and ratchet base (330) overlap in the used state.

In an alternative example, shaft assembly (314) mechanically andacoustically couples to handle assembly (312) by rotation in theopposite direction to the directions discussed above. First wheelratchet usage indicator (316) would thus cooperate with housing portion(320) upon disconnection, rather than connection, of shaft assembly(314) to handle assembly (312). More particularly, upon disconnection ofshaft assembly (314), rotating outer tube (34) counterclockwise wouldthereby rotate actuator (322) about the longitudinal axis while engagedwith wheel ratchet (336). The angular position of wheel ratchet (336)may thus be alternatively configured to indicate to the clinician theuse remaining state as it is rotated in the counterclockwise directiontoward the used state by successive disconnections of replacement shaftassemblies (314). The particular use cycle indications may progress uponeither connection or disconnection of shaft assembly (312) for thisexample and other examples described herein.

D. Second Wheel Ratchet Usage Indicator

FIGS. 17-19 illustrate a fifth exemplary ultrasonic surgical instrument(410) having a handle assembly (412) configured to be operated up to apredetermined number of use cycles, a shaft assembly (414) configuredfor a single use cycle of treatment, and a second wheel ratchet usageindicator (416). Second wheel ratchet usage indicator (416) isintegrated into portions of shaft assembly (414) and a housing (418) ofhandle assembly (412) for recording and indicating each respective usecycle of handle assembly (412) in a use remaining state to a used state.Second wheel ratchet usage indicator (416) has a shaft portion (419)that cooperates with a housing portion (420) upon connection of shaftassembly (414) to handle assembly (412) to thereby direct second wheelratchet usage indicator (416) toward the used state with eachreplacement shaft assembly (414). Once shaft assembly (414) has beenreplaced the predetermined number of use cycles, second wheel ratchetusage indicator (416) indicates the used state of handle assembly (412)to the clinician. Such indication of second wheel ratchet usageindicator (416) is visual as well as a lockout, which inhibits operationof handle assembly (412).

As shown in FIGS. 18-19, shaft portion (419) of second wheel ratchetusage indicator (416) includes a cylindrical distal end actuator (422)extending proximally from outer tube (34) toward housing portion (420).Housing portion (420) of second wheel ratchet usage indicator (416)includes distal and proximal housing mounts (324, 326) (see FIG. 14) anda clutch arrangement (428) mounted therebetween. Clutch arrangement(428) more particularly includes a ratchet plate (430) with a pluralityof ramp ratchet teeth (432), a biasing element, such as a compressedwave spring (434), and a wheel ratchet (436). Wheel ratchet (436) isrotatably mounted about the longitudinal axis and has a plurality ofslip ratchet teeth (438). Wheel ratchet (436) is thus configured toindicate usage through an indicia window (440) extending through a sidesurface of housing (418) as discussed below in greater detail.Compressed wave spring (434) is longitudinally captured between wheelratchet (436) and ratchet plate (430) and thereby biases wheel ratchet(436) and ratchet plate (430) away from each other.

Wheel ratchet (436) and ratchet plate (430) are generally cylindricaland coaxially aligned along the longitudinal axis such that slip ratchetteeth (438) and base ratchet teeth (432) are angularly positioned aboutthe longitudinal axis. Each of wave spring (434), ratchet plate (430),and wheel ratchet (436) further includes a longitudinally extending holetherethrough configured to receive waveguide (38) (see FIG. 4) forconnection within ultrasonic transducer (26) (see FIG. 4). Without shaftassembly (414) introduced in handle assembly (412), ratchet plate (430)is disengaged from wheel ratchet (436) and thus unable to rotate wheelratchet (436). In addition, wheel ratchet (436) further includes anarrester (not shown) to inhibit inadvertent clockwise orcounterclockwise rotation. In the present example, “clockwise” and“counterclockwise” refer to rotation of wheel ratchet (436) as viewedfrom a distal end of clutch arrangement (428).

In the present example, shaft assembly (414) mechanically andacoustically couples to handle assembly (412) by rotation similar toshaft and handle assemblies (114, 112) (see FIG. 7D). Insertion of outertube (34) into housing (418) engages actuator (422) into frictionalengagement with ratchet plate (430) by overcoming wave spring (434) biasand urging ratchet plate (430) proximally such that ramp ratchet teeth(432) of ratchet plate (430) engage with slip ratchet teeth (438) ofwheel ratchet (436). Rotating outer tube (34) clockwise for mechanicalconnection similarly rotates actuator (422) about the longitudinal axisand simultaneously rotates wheel ratchet (436) for each connection of areplacement shaft assembly (414) to handle assembly (412). Moreparticularly, engagement portions (433 a) of ramp ratchet teeth (432)engage slip ratchet teeth (438) to overcome arrester (not shown) in theclockwise direction for connection of shaft assembly (414). In contrast,ramp portions (433 b) of ramp ratchet teeth (432) are unable to overcomearrester (not shown) and thus simply slip by slip ratchet teeth (438) inthe counterclockwise direction for removal of shaft assembly (414).

As briefly discussed above, indicia window (440) provides clinician withvisual identification of the angular position of wheel ratchet (436).The relative angular position is recorded by a series of counter indices(444), which are angularly positioned about wheel ratchet (436) andincreasing in the clockwise direction. The present example of counterindices (444) includes clockwise increasing numbers “1,” “2,” “3,” “4,”and “5” and are respectively configured to correspond to eachreplacement shaft assembly (414) used with handle assembly (412) inrelation to the rotational position of wheel ratchet (436). For example,as shown in FIG. 17, a first counter indicia (444) “1” transverselyaligns through indicia window (440) to indicate to the clinician thathandle assembly (412) is in its first use.

Successive connections of replacement shaft assemblies (414) continue torotate wheel ratchet (436) until a fifth counter indicia (444) “5”transversely aligns through indicia window (440) to visually indicatethe used state of handle assembly (412). In addition, clutch arrangement(428) is configured to mechanically inhibit further connection ofreplacement shaft assemblies (414) greater than the predetermined numberof use cycles. More particularly, arrester (not shown) engages wheelratchet (436) in the used state to inhibit further counterclockwiserotation thereof. Second wheel ratchet usage indicator (416) is therebyconfigured to inhibit inadvertently using handle assembly (412) beyondthe predetermined number of use cycles.

In use, with respect to FIGS. 18-19, the clinician connects firstreplacement shaft assembly (414) to handle assembly (412) such thatactuator (422) urges wheel ratchet (436) in alignment with the firstindicia (444) for indicating the first use to clinician. Followingtreatment of the patient, shaft assembly (414) is disconnected fromhandle assembly (412) by slipping ramp portions (433 b) of ramp ratchetteeth (432) by slip ratchet teeth (438). Handle assembly (412) is thenprepped, such as by heating and/or sterilizing, for another surgicalprocedure and another replacement shaft assembly (414) is connected tohandle assembly (412). Actuator (426) of the second replacement shaftassembly (414) urges wheel ratchet (436) in alignment with the secondindicia for indicating the second use to the clinician. Such reusecontinues in the remaining use state until arrester (not shown) engageswheel ratchet (436) in the used state.

E. Third Wheel Ratchet Usage Indicator

FIGS. 20-25C illustrate a sixth exemplary ultrasonic surgical instrument(510) having a handle assembly (512) configured to be operated up to apredetermined number of use cycles, a shaft assembly (514) configuredfor a single use cycle of treatment, and a third wheel ratchet usageindicator (516). With respect to FIGS. 20-21, third wheel ratchet usageindicator (516) is integrated into portions of shaft assembly (514) anda housing (518) of handle assembly (512) for recording and indicatingeach respective use cycle of handle assembly (512) in a use remainingstate to a used state. Third wheel ratchet usage indicator (516) has ashaft portion (519) that cooperates with a housing portion (520) uponconnection of shaft assembly (514) to handle assembly (512) to therebydirect third wheel ratchet usage indicator (516) toward the used statewith each replacement shaft assembly (514). Once shaft assembly (514)has been replaced the predetermined number of use cycles, third wheelratchet usage indicator (516) indicates the used state of handleassembly (512) to the clinician. Such indication of third wheel ratchetusage indicator (516) is visual as well as a lockout, which inhibitsoperation of handle assembly (512).

As shown in FIGS. 21-23B, shaft portion (519) of third wheel ratchetusage indicator (516) includes an outer surface of outer tube (34) as anactuator (522). Housing portion (520) of third wheel ratchet usageindicator (516) includes a ratchet knob (542) having a knob cover (524),which includes an indicia window (528). Ratchet knob (542) operatessimilar to knob (42) (see FIG. 2) once receiving outer tube (34) fortreatment, but is a portion of housing (518) rather than shaft assembly(514). Ratchet knob (542) more particularly includes a ratchet mechanism(530) with a ratchet pawl tooth (532), a biasing element, such as atension spring (534), and a wheel ratchet (536). Wheel ratchet (536) isrotatably mounted about the longitudinal axis and has a plurality ofslip ratchet teeth (538). Wheel ratchet (536) is thus configured toindicate usage through indicia window (528) in knob cover (524) asdiscussed below in greater detail.

Wheel ratchet (536) generally cylindrical and coaxially aligned alongthe longitudinal axis such that slip ratchet teeth (538) are angularlypositioned about the longitudinal axis. Wheel ratchet (536) furtherincludes a longitudinally extending hole therethrough configured toreceive waveguide (38) (see FIG. 4) for connection within ultrasonictransducer (26) (see FIG. 4). Ratchet pawl tooth (532) of ratchetmechanism (530) is configured to urge wheel ratchet (536)counterclockwise, but inhibit clockwise rotation. In addition, thirdwheel ratchet usage indicator (516) further includes an arrester (540).Arrester (540) has a plurality of detents (544) configured to engage aproximal end of wheel ratchet (536) to further inhibit inadvertentclockwise or counterclockwise rotation wheel ratchet (536). In thepresent example, “clockwise” and “counterclockwise” refer to rotation ofwheel ratchet (536) as viewed from a distal end of ratchet knob (542).

With respect to FIGS. 23A-23B, ratchet mechanism includes a base (546)that movably receives a pivot core (548). Pivot core (548) has an outerslot (550) that spirals about an outer surface of the pivot core (548)such that rotation of pivot core (548) also causes pivot core (548) totransversely move upward and downward within base (546) betweenrespective contracted and expanded states. Ratchet pawl tooth (532)extends radially outward from pivot core (548) to similarly pivot andtransversely move therewith for urging movement of wheel ratchet (536)when shaft assembly (514) is inserted into ratchet knob (542).

To this end, a lever (552) extends transversely downward from pivot core(548) and into a longitudinal bore (554) through ratchet knob (542) toengage actuator (522) upon connection of shaft assembly (514) withhandle assembly (512). As shown in FIG. 24A, lever (522) is in the pathalong which outer tube (34) is inserted into longitudinal bore such thatactuator (522) engages lever (522) to rotate lever and, in turn, rotatepivot core (548) to urge wheel ratchet (536). Lever (522) also movestransversely upward with pivot core (548) as lever (522) rotates inorder to transversely clear the introduction path of outer tube (34) asshown in FIG. 24B.

In the present example, with respect to FIG. 25A, shaft assembly (514)mechanically and acoustically couples to handle assembly (512) byrotation similar to shaft and handle assemblies (114, 112) (see FIG.7D). Insertion of outer tube (34) into housing (518) rotates lever(522), pivot core (548), and ratchet pawl tooth (532). With ratchet pawltooth (532) engaged with one of slip ratchet teeth (538), rotation ofratchet pawl tooth (532) thereby urges wheel ratchet (536) withsufficient force to overcome arrester (540). Removal of outer tube (34)from housing (518) causes, tension spring (534) to rotate pivot core(548) back such that ratchet pawl tooth (532) slips in the clockwisedirection along slip ratchet teeth (538). Arrester (540) is configuredto secure wheel ratchet (536) such that ratchet pawl tooth (532) slipsin the clockwise direction without also rotating wheel ratchet (536) inthe clockwise direction. Ratchet pawl tooth (532) and slip ratchet teeth(538) each include engagement and ramp portions (556 a, 556 b) tofurther aid to respective urging and slipping of wheel ratchet (536)similar to those discussed above in other examples herein.

As briefly discussed above, indicia window (528) (see FIG. 20) providesclinician with visual identification of the angular position of wheelratchet (536). The relative angular position is recorded by a series ofcounter indices (558), which are angularly positioned about wheelratchet (536) and increasing in the clockwise direction. The presentexample of counter indices (558) includes clockwise increasing numbers“1,” “2,” “3,” “4,” and “5” and are respectively configured tocorrespond to each replacement shaft assembly (514) used with handleassembly (512) in relation to the rotational position of wheel ratchet(536). For example, as shown in FIG. 20 and FIG. 25A, a first counterindicia (558) “1” transversely aligns through indicia window (528) toindicate to the clinician that handle assembly (512) is in its firstuse.

Successive connections of replacement shaft assemblies (414) continue torotate wheel ratchet (536) until a fifth counter indicia (544) “5”transversely aligns through indicia window (528) to visually indicatethe used state of handle assembly (512). In addition, ratchet knob (542)is configured to mechanically inhibit further connection of replacementshaft assemblies (514) greater than the predetermined number of usecycles. More particularly, arrester (540) engages wheel ratchet (536) inthe used state to inhibit further counterclockwise rotation thereof.Third wheel ratchet usage indicator (516) is thereby configured toinhibit inadvertently using handle assembly (512) beyond thepredetermined number of use cycles.

In use, with respect to FIGS. 25A-25C, the clinician connects firstreplacement shaft assembly (514) to handle assembly (512) such thatactuator (522) urges wheel ratchet (536) in alignment with the firstindicia (558) for indicating the first use to clinician. Followingtreatment of the patient, shaft assembly (514) is disconnected fromhandle assembly (512) by slipping ramp portions (556 b) of ratchet pawltooth (532) by slip ratchet teeth (538). Handle assembly (512) is thenprepped, such as by heating and/or sterilizing, for another surgicalprocedure and another replacement shaft assembly (514) is connected tohandle assembly (512). Actuator (522) of the second replacement shaftassembly (514) urges wheel ratchet (536) in alignment with the secondindicia for indicating the second use to the clinician. Such reusecontinues in the remaining use state until arrester (540) engages wheelratchet (536) in the used state.

F. Fourth Wheel Ratchet Usage Indicator

FIGS. 26-28C illustrate a seventh exemplary ultrasonic surgicalinstrument (610) having a handle assembly (612) configured to beoperated up to a predetermined number of use cycles, shaft assembly (14)configured for a single use cycle of treatment, and a fourth wheelratchet usage indicator (616). With respect to FIGS. 26-27, fourth wheelratchet usage indicator (616) is integrated into a housing (618) ofhandle assembly (612) for recording and indicating each respective usecycle of handle assembly (612) in a use remaining state to a used state.Fourth wheel ratchet usage indicator (616) has a housing portion (620)that cooperates with shaft assembly (14) upon connection of shaftassembly (14) to handle assembly (612) to thereby direct fourth wheelratchet usage indicator (616) toward the used state with eachreplacement shaft assembly (14). Once shaft assembly (14) has beenreplaced the predetermined number of use cycles, fourth wheel ratchetusage indicator (616) indicates the used state of handle assembly (612)to the clinician. Such indication of fourth wheel ratchet usageindicator (616) is visual as well as a lockout, which inhibits operationof handle assembly (612).

Housing portion (620) of fourth wheel ratchet usage indicator (616)includes an actuator (622), an indicia window (628) through housing(618), a rotatable wheel mount (624), a ratchet mechanism (630), and awheel ratchet (636). Actuator (622) of the present example is a distalend of ultrasonic transducer (26). Wheel ratchet (636) is rotatablymounted to wheel mount (624) within housing (618), whereas ratchetmechanism (630) is translatably mounted within housing (618) and biasedin the proximal direction toward actuator ultrasonic transducer (26). Inthe present example, threadably connecting waveguide (38) to ultrasonictransducer (26) distally pulls ultrasonic transducer (26) from aproximal position to a distal position. Thereby, actuator (622) isconfigured to distally urge ratchet mechanism (630) into engagement withwheel ratchet (636) for rotating wheel ratchet (636) while wheel ratchet(636) is visible to clinician through indicia window (628) as discussedbelow in greater detail.

In the present example, ratchet mechanism (630) is a pawl tab (632)configured to be distally translated by actuator (622) as ultrasonictransducer (26) slides from the proximal position to the distalposition. Pawl tab (632) is more particularly rigid in the longitudinaldirection so as to engage and rotate wheel ratchet (636), butresiliently deflectable in the lateral direction. Wheel ratchet (636)has an upper ratchet gear (638) with a plurality of radially projectingslip ratchet teeth (640) about rotatable wheel mount (624). Upperratchet gear (638) is attached to and extending upward from a lowerwheel body (640). Pawl tab (632) is thus configured to engage slipratchet teeth (640) while moving the distal direction and urge wheelratchet (636) in the clockwise direction, but inhibit movement in thecounterclockwise direction. In addition, fourth wheel ratchet usageindicator (616) further includes an arrester (644). Arrester (644) has aplurality of detent tabs (646) configured to engage a detent catch (notshown) below lower wheel body (642) and fixed within housing (618).Cooperation between detent tabs (646) positioned on lower wheel body(640) and detent catch (not shown) further inhibits inadvertentclockwise or counterclockwise rotation of wheel ratchet (636). In thepresent example, “clockwise” and “counterclockwise” refer to rotation ofwheel ratchet (636) as viewed from a top view of wheel ratchet (636).

In the present example, with respect to FIG. 28A-28C, shaft assembly(14) mechanically and acoustically couples to handle assembly (612) byrotation similar to shaft and handle assemblies (114, 112) (see FIG.7D). Threadably connecting waveguide (38) with ultrasonic transducer(26) distally pulls ultrasonic transducer (26) with actuator (622) intoengagement with pawl tab (632) of ratchet mechanism (630). Pawl tab(632) in turn urges slip ratchet teeth (40) clockwise direction withsufficient force to overcome arrester (640). Disconnecting waveguide(38) from ultrasonic transducer (26) causes ultrasonic transducer (26)with actuator (622) to proximally return to the proximal position suchthat pawl tab (632) slips proximally along slip ratchet teeth (640).Arrester (640) is configured to secure wheel ratchet (636) such thatpawl tab (632) slips without also rotating wheel ratchet (636) in thecounterclockwise direction. Slip ratchet teeth (640) each includeengagement and ramp portions (648 a, 648 b) to further aid to respectiveurging and slipping of wheel ratchet (636) similar to those discussedabove in other examples herein.

As briefly discussed above, indicia window (628) (see FIG. 26) providesclinician with visual identification of the angular position of wheelratchet (636). The relative angular position is recorded by a series ofcounter indices (650), which are angularly positioned about wheelratchet (636) and increasing in the counterclockwise direction. Thepresent example of counter indices (636) includes counterclockwiseincreasing numbers “1,” “2,” “3,” “4,” and “5” and are respectivelyconfigured to correspond to each replacement shaft assembly (14) usedwith handle assembly (612) in relation to the rotational position ofwheel ratchet (636). For example, as shown in FIG. 26 and FIG. 28A, afirst counter indicia (650) “1” transversely aligns through indiciawindow (628) to indicate to the clinician that handle assembly (612) isin its first use.

Successive connections of replacement shaft assemblies (14) continue torotate wheel ratchet (636) until a fifth counter indicia (650) “5”transversely aligns through indicia window (628) to visually indicatethe used state of handle assembly (612). In addition, fourth wheelratchet usage indicator (616) is configured to mechanically inhibitfurther connection of replacement shaft assemblies (14) greater than thepredetermined number of use cycles. More particularly, arrester (644)engages wheel ratchet (636) in the used state to inhibit furtherclockwise rotation thereof. Fourth wheel ratchet usage indicator (616)is thereby configured to inhibit inadvertently using handle assembly(612) beyond the predetermined number of use cycles.

In use, with respect to FIGS. 28A-28C, the clinician connects firstreplacement shaft assembly (14) to handle assembly (612) such thatactuator (622) urges wheel ratchet (636) in alignment with the firstindicia (650) for indicating the first use to clinician. Followingtreatment of the patient, shaft assembly (14) is disconnected fromhandle assembly (612) by slipping pawl tab (632) by ramp portions (648b) of slip ratchet teeth (640). Handle assembly (612) is then prepped,such as by heating and/or sterilizing, for another surgical procedureand another replacement shaft assembly (614) is connected to handleassembly (612). Actuator (622) of the second replacement shaft assembly(614) urges wheel ratchet (636) in alignment with the second indicia forindicating the second use to the clinician. Such reuse continues in theremaining use state until arrester (644) engages wheel ratchet (636) inthe used state.

G. Fifth Wheel Ratchet Usage Indicator

FIGS. 29-31B illustrate an eighth exemplary ultrasonic surgicalinstrument (710) having a handle assembly (712) configured to beoperated up to a predetermined number of use cycles, a shaft assembly(714) configured for a single use cycle of treatment, and a fifth wheelratchet usage indicator (716). With respect to FIGS. 29-30, fifth wheelratchet usage indicator (716) is integrated into a housing (718) ofhandle assembly (712) for recording and indicating each respective usecycle of handle assembly (712) in a use remaining state to a used state.Fifth wheel ratchet usage indicator (716) has a housing portion (720)that cooperates with shaft assembly (714) upon connection of shaftassembly (714) to handle assembly (712) to thereby direct fifth wheelratchet usage indicator (716) toward the used state with eachreplacement shaft assembly (714). Once shaft assembly (714) has beenreplaced the predetermined number of use cycles, fifth wheel ratchetusage indicator (716) indicates the used state of handle assembly (712)to the clinician. Such indication of fifth wheel ratchet usage indicator(716) is visual as well as a lockout, which inhibits operation of handleassembly (712).

Shaft assembly (714) has outer tube (34) with a distal end actuator(722), whereas housing portion (720) of fifth wheel ratchet usageindicator (716) includes, an indicia window (728) through housing (718),a rotatable wheel mount (724), a ratchet mechanism (730), and a wheelratchet (736). Wheel ratchet (736) is rotatably mounted to wheel mount(724) within housing (718), whereas ratchet mechanism (730) istranslatably mounted within housing (718) and biased in the distaldirection toward distal end actuator (722) of outer tube (34). In thepresent example, insertion of outer tube (34) into housing (718) causesdistal end actuator (722) to proximally urge ratchet mechanism (730)into engagement with wheel ratchet (736) for rotating wheel ratchet(736) while wheel ratchet (736) is visible to clinician through indiciawindow (728) as discussed below in greater detail.

In the present example, ratchet mechanism (730) includes a translatablemember (731), a pivotal pawl (732) connected to a distal end portion oftranslatable member (731), and a biasing member, such as a tensionspring (734). Tension spring (734) biases translatable member (731) withpivotal pawl (732) carried thereon in the distal direction forengagement with distal end actuator (722) of outer tube (34). Thus,pivotal pawl (732) is configured to be proximally translated by distalend actuator (722) outer tube (34) slides into housing (718).

Wheel ratchet (736) is generally cylindrical and has a plurality ofradially projecting slip ratchet teeth (740) about rotatable wheel mount(724). Pivotal pawl (732) is thus configured to engage slip ratchetteeth (740) while moving the proximal direction and urge wheel ratchet(736) in the clockwise direction, but inhibit movement in thecounterclockwise direction. In addition, fifth wheel ratchet usageindicator (716) further includes an arrester (744). Arrester (744) has aresiliently mounted arrester pawl (746) and a brake member (747)configured to engage slip ratchet teeth (740) and collectively inhibitinadvertent counterclockwise rotation of wheel ratchet (636). Moreparticularly, arrester pawl (746) inhibits counterclockwise rotation ofwheel ratchet (736) by engagement with slip ratchet teeth (740), butslips along slip ratchet teeth (740) during clockwise rotation. Brakemember (747) generally frictionally engages wheel ratchet (736) toinhibit inadvertent clockwise and counterclockwise rotation and isfurther configured to lock movement of wheel ratchet (736) in the usedstate. In the present example, “clockwise” and “counterclockwise” referto rotation of wheel ratchet (736) as viewed from a side view of wheelratchet (736) in FIGS. 30-31B.

In the present example, with respect to FIG. 31A-31B, shaft assembly(714) mechanically and acoustically couples to handle assembly (712) byrotation similar to shaft and handle assemblies (114, 112) (see FIG.7D). Insertion of outer tube (34) into housing (718) causes distal endactuator (722) to engage translatable member (731) and collectivelyslide translatable member (731) and pivotal pawl (732) in the proximaldirection toward wheel ratchet (740). Pivotal pawl (732) pivots toeffectively ride along slip ratchet teeth (740) and accommodate rotationof slip ratchet teeth (740) while maintaining engagement therewith.Pivotal pawl (732) in turn urges slip ratchet teeth (740) in theclockwise direction with sufficient force to overcome arrester (740).Disconnecting shaft assembly (714) from handle assembly (712) causeswith distal end actuator (722) to proximally disengage from translatablemember (731). Translatable member (731) and pivotal pawl (732) therebyreturn to the distal position such that pivotal pawl (732) slipsdistally along slip ratchet teeth (740). Arrester (740) is configured tosecure wheel ratchet (736) such that pivotal pawl (732) slips withoutalso rotating wheel ratchet (736) in the counterclockwise direction.Slip ratchet teeth (740) and arrester pawl (746) each include engagementand ramp portions (748 a, 748 b) to further aid to respective urging andslipping of wheel ratchet (736) similar to those discussed above inother examples herein.

As briefly discussed above, indicia window (728) (see FIG. 29) providesclinician with visual identification of the angular position of wheelratchet (736). The relative angular position is recorded by a series ofcounter indices (750), which are angularly positioned about wheelratchet (736) and increasing in the clockwise direction. The presentexample of counter indices (736) includes clockwise increasing numbers“1,” “2,” “3,” “4,” and “5” and are respectively configured tocorrespond to each replacement shaft assembly (714) used with handleassembly (712) in relation to the rotational position of wheel ratchet(736). In the present example, such correspondence indicates the amountof use cycles remaining and thus, progressively decreases with use. Forexample, as shown in FIG. 29, a first counter indicia (750) “1” alignsthrough indicia window (728) to indicate to the clinician that handleassembly (712) has one use remaining. Alternatively, counter indices(736) may be counterclockwise increasing numbers in order to indicatethe cumulative use cycles of handle assembly (712). The invention isthus not intended to be unnecessarily limited to increasing ordecreasing numerical indices for the present example or other examplesdescribed herein.

Successive connections of replacement shaft assemblies (714) continue torotate wheel ratchet (736) until a fifth counter indicia (750) “5”aligns through indicia window (728) to visually indicate the used stateof handle assembly (712) as shown in FIGS. 31A-31B. In addition, fifthwheel ratchet usage indicator (716) is configured to mechanicallyinhibit further connection of replacement shaft assemblies (714) greaterthan the predetermined number of use cycles. More particularly, brakemember (748) of arrester (744) engages wheel ratchet (736) in the usedstate to inhibit further clockwise rotation thereof. Fifth wheel ratchetusage indicator (716) is thereby configured to inhibit inadvertentlyusing handle assembly (712) beyond the predetermined number of usecycles.

In use, with respect to FIGS. 31A-31B, the clinician connects firstreplacement shaft assembly (714) to handle assembly (712) such thatactuator (722) urges wheel ratchet (736) in alignment with the firstindicia (750) for indicating the first use to clinician. Followingtreatment of the patient, shaft assembly (714) is disconnected fromhandle assembly (712) by slipping pivotal pawl (732) by ramp portions(748 b) of slip ratchet teeth (740). Handle assembly (712) is thenprepped, such as by heating and/or sterilizing, for another surgicalprocedure and another replacement shaft assembly (714) is connected tohandle assembly (712). Distal end actuator (722) of the secondreplacement shaft assembly (714) urges wheel ratchet (736) in alignmentwith the second indicia for indicating the second use to the clinician.Such reuse continues in the remaining use state until arrester (744)engages wheel ratchet (736) in the used state.

H. Linear Ratchet Usage Indicator

FIGS. 32A-33C illustrate a linear ratchet usage indicator (816) for usewith handle assembly (712) and shaft assembly (714) shown in FIG. 29.Similar to fifth wheel ratchet usage indicator (716) discussed above,linear ratchet usage indicator (816) is integrated into housing (718) ofhandle assembly (712) for recording and indicating each respective usecycle of handle assembly (712) in a use remaining state to a used state.Linear ratchet usage indicator (816) has a housing portion (820) thatcooperates with shaft assembly (714) upon connection of shaft assembly(714) to handle assembly (712) to thereby direct linear ratchet usageindicator (816) toward the used state with each replacement shaftassembly (714). Once shaft assembly (714) has been replaced thepredetermined number of use cycles, linear ratchet usage indicator (816)indicates the used state of handle assembly (712) to the clinician. Suchindication of linear ratchet usage indicator (816) is visual as well asa lockout, which inhibits operation of handle assembly (712).

Shaft assembly (714) has outer tube (34) with distal end actuator (722),whereas housing portion (820) of linear ratchet usage indicator (816)includes ratchet mechanism (730) as discussed above as well as a linearmount (824) and a linear ratchet (736). Linear ratchet (736) istranslatably mounted to linear mount (824) and biased in the distaldirection toward ratchet mechanism (730). In the present example,insertion of outer tube (34) into housing (718) causes distal endactuator (722) to proximally urge ratchet mechanism (730) intoengagement with linear ratchet (836) for proximally translating linearratchet (836) while linear ratchet (836) is visible to clinician throughindicia window (728) as discussed below in greater detail.

Linear ratchet (836) generally includes an elongate plate body (838)having a series of upper and lower transversely projecting slip ratchetteeth (840 a, 840 b). Upper and lower slip ratchet teeth (840 a, 840 b)are respectively linearly aligned and extending upward and downward fromelongate plate body (838). Pivotal pawl (732) is thus configured toengage upper slip ratchet teeth (840) while moving in the proximaldirection and urge linear ratchet (836) in the proximal direction, butinhibit movement in the distal direction. In addition, linear ratchetusage indicator (816) further includes an arrester (844). Arrester (844)has a resiliently mounted arrester pawl (846) configured to engage lowerslip ratchet teeth (840 b) to inhibit inadvertent distal movement oflinear ratchet (836). While not shown in the present example, arrester(844) may further include a brake member (not shown) similar to brakemember (747) (see FIG. 30) discussed above for further inhibitinginadvertent proximal and distal movement of linear ratchet (836).

As briefly discussed above, indicia window (728) (see FIG. 29) providesclinician with visual identification of the longitudinal position oflinear ratchet (836). The relative longitudinal position is recorded bya series of counter indices (850), which are longitudinally positionedalong linear ratchet (836) and increasing in the counterclockwisedirection. The present example of counter indices (736) includesdistally increasing numbers “1,” “2,” “3,” “4,” and “5” and arerespectively configured to correspond to each replacement shaft assembly(714).

Successive connections of replacement shaft assemblies (714) continue toproximally translate linear ratchet (836) until a fifth counter indicia(850) “5” aligns through indicia window (728). In addition, linearratchet usage indicator (816) is configured to mechanically inhibitfurther connection of replacement shaft assemblies (814) greater thanthe predetermined number of use cycles. More particularly, linearratchet (836) is configured to cease further proximal translation in theused state to thereby inhibit inadvertently using handle assembly (712)(see FIG. 29) beyond the predetermined number of use cycles.

In use, with respect to FIGS. 29 and 32A-32C, the clinician connectsfirst replacement shaft assembly (714) to handle assembly (712) suchthat actuator (722) urges linear ratchet (836) in alignment with thefirst indicia (850) for indicating the first use to clinician. Followingtreatment of the patient, shaft assembly (714) is disconnected fromhandle assembly (712) by slipping pivotal pawl (732) by ramp portions(748 b) of slip ratchet teeth (840 a). Handle assembly (712) is thenprepped, such as by heating and/or sterilizing, for another surgicalprocedure and another replacement shaft assembly (714) is connected tohandle assembly (712). Distal end actuator (722) of the secondreplacement shaft assembly (714) urges linear ratchet (836) in alignmentwith the second indicia for indicating the second use to the clinician.Such reuse continues in the remaining use state until linear ratchet(836) translates proximally to the used state to inhibit furtherattachment of additional replacement shaft assemblies (714).

I. Slip Ratchet Usage Indicator

FIGS. 33-35E illustrate a ninth exemplary ultrasonic surgical instrument(910) having a handle assembly (912) configured to be operated up to apredetermined number of use cycles, a shaft assembly (914) configuredfor a single use cycle of treatment, and a slip ratchet usage indicator(916). With respect to FIGS. 33-34, slip ratchet usage indicator (916)is integrated into portions of shaft assembly (914) and a housing (918)of handle assembly (912) for recording and indicating each respectiveuse cycle of handle assembly (912) in a use remaining state to a usedstate. Slip ratchet usage indicator (916) has a shaft portion (919) thatcooperates with a housing portion (920) upon connection of shaftassembly (914) to handle assembly (912) to thereby direct slip ratchetusage indicator (916) toward the used state with each replacement shaftassembly (914). Once shaft assembly (914) has been replaced thepredetermined number of use cycles, slip ratchet usage indicator (916)indicates the used state of handle assembly (912) to the clinician. Suchindication of slip ratchet usage indicator (916) is visual as well as alockout, which inhibits operation of handle assembly (912).

As shown in FIGS. 34-35A, shaft portion (919) of slip ratchet usageindicator (916) includes an actuator (922) positioned on outer tube(34). Actuator (34) of the present example includes a receiving slot(923) and a follower slot (924). Housing portion (920) of slip ratchetusage indicator (916) includes a wheel ratchet (936) having a pluralityof slip ratchet teeth (938) angularly positioned about and extendingradially outward from a rotatable shaft (939). Wheel ratchet (936) isratcheted to rotate in a clockwise direction, but not rotate in thecounterclockwise direction. Wheel ratchet (936) is thus configured toindicate usage through an indicia window (940) extending through anupper surface of housing (918) as discussed below in greater detail. Inaddition, wheel ratchet (936) further includes an arrester (not shown)to inhibit inadvertent clockwise or counterclockwise rotation. In thepresent example, “clockwise” and “counterclockwise” refer to rotation ofwheel ratchet (936) as viewed from a distal end of wheel ratchet (936).

In the present example, shaft assembly (914) mechanically andacoustically couples to handle assembly (912) by rotation similar toshaft and handle assemblies (114, 112) (see FIG. 7D). As outer tube (34)is inserted into housing (918) as shown in FIGS. 35A-35B, receiving slot(923) in outer tube (34) translatably receives a lower slip ratchettooth (938). Rotating outer tube (34) for connection to shaft assembly(914) in the clockwise direction causes actuator (922) to similarlyrotate wheel ratchet (936) in the counterclockwise direction. Followerslot (924) then radially receives an adjacent slip ratchet tooth (938)as shown in FIGS. 35C-35D, at which point outer tube (34) ismechanically coupled with handle assembly (912).

Upon removal of shaft assembly (914), outer tube (34) is rotatedcounterclockwise as shown in FIG. 35E. However, because wheel ratchet(936) is ratcheted as discussed above, wheel ratchet (936) does notrotate clockwise upon engaged with actuator (922) with slip ratchettooth (938) in follower slot (924). Instead, outer tube (34) compressesslip ratchet tooth (938) and slips counterclockwise along slip ratchettooth (938) until slip ratchet tooth (938) is again radially receivedback in receiving slot (923) for removal of outer tube (34) from handleassembly (912). Such urging and slipping of wheel ratchet (936) isfurther aided by engagement and ramp portions (942 a, 942 b) of slipratchet teeth (938) similar to those discussed above in other examplesherein. The angular position of wheel ratchet (936) is thus configuredto indicate to the clinician the use remaining state as it is rotated inthe counterclockwise direction toward the used state by successiveconnections of replacement shaft assemblies (914).

As briefly discussed above, indicia window (940) provides clinician withvisual identification of the angular position of wheel ratchet (936).The relative angular position is recorded by a series of counter indices(944), which are angularly positioned about wheel ratchet (936) andincreasing in the counterclockwise direction. The present example ofcounter indices (944) includes clockwise increasing numbers “1,” “2,”“3,” and “4,” and are respectively configured to correspond to eachreplacement shaft assembly (914) used with handle assembly (912) inrelation to the rotational position of wheel ratchet (936). For example,as shown in FIGS. 33-34, a first counter indicia (944) “1” transverselyaligns through indicia window (940) to indicate to the clinician thathandle assembly (912) is in its first use.

Successive connections of replacement shaft assemblies (914) continue torotate wheel ratchet (936) until a fourth counter indicia (944) “4”transversely aligns through indicia window (440) to visually indicatethe used state of handle assembly (912). In addition, slip ratchet usageindicator (916) may further include arrester (not shown) to mechanicallyinhibit further connection of replacement shaft assemblies (914) greaterthan the predetermined number of use cycles. Slip ratchet usageindicator (916) is thereby configured to inhibit inadvertently usinghandle assembly (912) beyond the predetermined number of use cycles.

In use, with respect to FIGS. 35A-35E, the clinician connects firstreplacement shaft assembly (914) to handle assembly (912) such thatactuator (2222) urges wheel ratchet (936) counterclockwise in alignmentwith the first indicia (944) for indicating the first use to clinician.Following treatment of the patient, shaft assembly (914) is disconnectedfrom handle assembly (912) while ratcheted wheel ratchet (936) remainsstationary relative to outer tube (34). Handle assembly (912) is thenprepped, such as by heating and/or sterilizing, for another surgicalprocedure and another replacement shaft assembly (914) is connected tohandle assembly (912). Actuator (926) of the second replacement shaftassembly (914) urges wheel ratchet (936) in alignment with the secondindicia for indicating the second use to the clinician. Such reusecontinues in the remaining use state until wheel ratchet (936) rotatescounterclockwise to the used state to inhibit further attachment ofadditional replacement shaft assemblies (914).

J. Cycle Response Usage Indicator

FIGS. 36-40B illustrate a tenth exemplary ultrasonic surgical instrument(1010) having a handle assembly (1012) configured to be operated up to apredetermined number of use cycles, shaft assembly (14) configured for asingle use cycle of treatment, and a cycle response usage indicator(1016). With respect to FIGS. 36-39, cycle response usage indicator(1016) is integrated into a housing (1018) of handle assembly (1012) forrecording and indicating each respective use cycle of handle assembly(1012) in a use remaining state to a used state. Cycle response usageindicator (1016) has a housing portion (1020) is configured to respondto a state of use that occurs once per usage cycle to thereby directcycle response usage indicator (1016) toward the used state. In thepresent example, cycle response usage indicator (1016) is directedtoward the used state each time cycle response usage indicator (1016) isincreased in temperature to a predetermined cleaning temperature. Oncehandle assembly (1012) has been repeatedly heated to the predeterminedcleaning temperature the predetermined number of use cycles, cycleresponse usage indicator (1016) indicates the used state of handleassembly (1012) to the clinician. Such indication of cycle responseusage indicator (1016) is visual as well as a lockout, which inhibitsoperation of handle assembly (1012).

As shown in FIGS. 37-40A, cycle response usage indicator (1016) includesa response actuator pawl (1028) rigidly mounted to shaft mount (1030)within a wheel ratchet (1036). Wheel ratchet (1036) is rotatable aboutshaft mount (1030) within housing (1018) and aligned with an indiciawindow (1040) for viewing the angler position of wheel ratchet (1036).Response actuator pawl (1028) is configured to direct rotation of wheelratchet (1036) by moving from a retracted state to an elongated stateupon being heated to the predetermined cleaning temperature as shownrespectively in FIG. 38 and FIG. 39. To this end, response actuator pawl(1028) of the present example is formed from a first material, such as afirst metal (1031), attached to a second material, such as a secondmetal (1032). The first and second metals (1031, 1032) have respectivefirst and second thermal coefficients of expansion configured tocollectively respond to heating such that response actuator pawl (1028)moves from the retracted state to the elongated state. Moreparticularly, the first coefficient of thermal expansion of first metal(1031) is less than the second coefficient of thermal expansion ofsecond metal (1032) such that second metal (1032) expands more thanfirst metal (1031) upon heating to the predetermined cleaningtemperature. Thereby, the greater expansion of second metal (1032)relative to first metal (1031) effectively rotates and straightensresponse actuator pawl (1028) for urging rotation of wheel ratchet(1036).

FIG. 40A shows response actuator pawl (1028) within wheel ratchet(1036). Response actuator pawl (1028) further includes an end tooth(1034), whereas wheel ratchet (1036) has a ring body (1037) andplurality of slip ratchet teeth (1038). Slip ratchet teeth (1038) extendinward from ring body (1037) and are positioned angularly about an innersurface of ring body (1037). In the retracted state, response actuatorpawl (1028) engages an upper slip ratchet tooth (1038), but as cycleresponse usage indicator (1016) is heated to the predetermined cleaningtemperature, response actuator pawl (1028) is configured to urge wheelratchet (1036) counterclockwise toward the used state as shown in FIGS.40B-40C. Cycle response usage indicator (1016) further includes anarrester (1042) to inhibit inadvertent clockwise or counterclockwiserotation. Arrester (1042) of the present example includes cooperatingdetents (1044) between housing (1018) and ring body (1037) to movablysecure the angular position of wheel ratchet (1036) with sufficientforce to inhibit such inadvertent rotation. In the present example,“clockwise” and “counterclockwise” refer to rotation of wheel ratchet(936) as viewed from a distal end of wheel ratchet (1036).

With respect to FIG. 40D, upon cooling of handle assembly (1012) fromthe predetermined cleaning temperature to the ambient temperature,response actuator pawl (1028) returns from the elongated state to theretracted state. However, because wheel ratchet (1036) is moveablysecured via arrester (1042) as discussed above, wheel ratchet (1036)does not rotate clockwise with response actuator pawl (1028). Instead,end tooth (1034) of response actuator pawl (1028) slips counterclockwisealong slip ratchet tooth (1038) until end tooth (1034) of responseactuator pawl (1028) is again engaged with slip ratchet tooth (1038) foran additional cycle use. Such urging and slipping between end tooth(1034) and slip ratchet teeth (1038) is further aided by engagement andramp portions (942 a, 942 b) of end tooth (1034) and slip ratchet teeth(938) similar to those discussed above in other examples herein. Theangular position of wheel ratchet (1036) is thus configured to indicateto the clinician the use remaining state as it is rotated in thecounterclockwise direction toward the used state by successive heatingto the predetermined cleaning temperature.

As briefly discussed above, indicia window (1040) provides clinicianwith visual identification of the angular position of wheel ratchet(1036). The relative angular position is recorded by a series of counterindices (1048), which are angularly positioned about wheel ratchet(1036) and increasing in the counterclockwise direction. The presentexample of counter indices (1048) includes clockwise increasing numbers“1,” “2,” “3,” and “4,” and are respectively configured to correspond toeach replacement shaft assembly (14) used with handle assembly (1012) inrelation to the rotational position of wheel ratchet (1036). Forexample, as shown in FIG. 36, a first counter indicia (1048) “1”transversely aligns through indicia window (1040) to indicate to theclinician that handle assembly (1012) is in its first use.

Successive heating to the predetermined cleaning temperature continue torotate wheel ratchet (1036) until a fourth counter indicia (1048) “4”transversely aligns through indicia window (1040) to visually indicatethe used state of handle assembly (1012). In addition, arrester (1042)may be further configured to inhibit connection of replacement shaftassemblies (1014) greater than the predetermined number of use cycles.Cycle response usage indicator (1016) is thereby configured to inhibitinadvertently using handle assembly (1212) beyond the predeterminednumber of use cycles. While the present example response actuator pawl(1028) is initially in the retracted state and straightens to theelongated state upon heating to the predetermined cleaning temperature,response actuator pawl (1028) may be alternatively configured toinitially be in either the retracted or elongated states. Responseactuator pawl (1028) may furthermore be configured to direct movement ofwheel ratchet (1036) when heated or cooled. It will be appreciated thatany combination of initial states of actuator pawl (1028) upon eitherheating or cooling may direct movement of actuator pawl (1028), and theinvention is thus not intended to be unnecessarily limited to theparticular states of actuator pawl (1028) shown and described herein.

In use, with respect to FIGS. 40A-40D, the clinician connects firstreplacement shaft assembly (14) to handle assembly (1012) and wheelratchet (1036) aligns with the first indicia (1048) for indicating thefirst use to clinician. Following treatment of the patient, shaftassembly (14) is disconnected from handle assembly (1012) whileratcheted wheel ratchet (1036) remains stationary relative to housing(1018). Handle assembly (1012) is then prepped, such as by heating andcleaning handle assembly (1012) up to the predetermined cleaningtemperature, for another surgical procedure. Heating handle assembly(1012) moves response actuator pawl (1028) from the retracted state tothe elongated state to urge wheel ratchet (1036) counterclockwiseanother use cycle toward the used state. and another replacement shaftassembly (914) is connected to handle assembly (912). A secondreplacement shaft assembly (14) may then be connected to handle assembly(1012) while indicating the second use to the clinician. Such reusecontinues in the remaining use state until wheel ratchet (1036) rotatescounterclockwise to the used state to inhibit further attachment ofadditional replacement shaft assemblies (14).

K. Circuit Usage Indicator

FIGS. 41-45B illustrate an eleventh exemplary ultrasonic surgicalinstrument (1110) having a handle assembly (1112) configured to beoperated up to a predetermined number of use cycles, shaft assembly (14)configured for a single use cycle of treatment, and a first circuitusage indicator (1116). With respect to FIGS. 41-42, first circuit usageindicator (1116) is integrated into a housing (1118) of handle assembly(1112) for recording and indicating each respective use cycle of handleassembly (1112) in a use remaining state to a used state. First circuitusage indicator (1116) has a housing portion (1120) is configured torespond to a state of use that occurs once per usage cycle to therebydirect first circuit usage indicator (1116) toward the used state. Inthe present example, first circuit usage indicator (1116) is directedtoward the used state each time shaft assembly (14) is connected tohandle assembly (1112). Once handle assembly (1112) has been repeatedlyused with replacement shaft assemblies (14), first circuit usageindicator (1116) indicates the used state of handle assembly (1112) tothe clinician. Such indication of first circuit usage indicator (1116)is visual as well as a lockout, which inhibits operation of handleassembly (1112).

First circuit usage indicator (1116) includes a memory, such as anEEPROM (1122), and a circuit board (1124) having an electrical circuit(1126). EEPROM (1122) is configured to detect and record each instancethat replacement shaft assemblies (14) are respectively connected tohandle assembly (1112). Electrical circuit (1126) further includes aplurality of removable electrical connections (1128), such as wires, anda respective plurality of use tabs (1130) that cover openings (1132) onan outer surface of housing (1118) as shown in FIG. 43.

With respect to FIG. 42 and FIGS. 44A-45B, each use tab (1130) ispivotally connected to housing (1118) and further includes a wedge(1134) extending laterally into housing (1118) toward removableelectrical connection (1128). With each use, the clinician manipulatesone respective use tab (1130) inward through opening (1132) such thatwedge (1134) breaks electrical connection (1124) for electrical removalfrom electrical circuit (1126). EEPROM (1122) adjusts electrical circuit(1126) based on each recorded connection of shaft assembly (14) toprevent electrical powering of ultrasonic transducer (26) handleassembly (1112) unless a subsequent use tab (1130) is depressed. EEPROM(1122) is thus configured to sense each respective electrical removal ofuse tabs (1130) and only allows electrical powering of ultrasonictransducer (26) after clinician removes electrical connection (1128)that correlates to the particular use cycle with replacement shaftassembly (14). For visual indication of use cycles, each use tab (1130)has a respective counter indicia (1136) that increases in the proximaldirection with numbers “1,” “2,” “3,” “4,” and “5” and are respectivelyconfigured to correspond to each replacement shaft assembly (14). Forexample, a first counter indicia (1136) “1” indicates to the clinicianthat handle assembly (1212) is in its first use.

Successive connections of replacement shaft assemblies (14) continue torequire the clinician to remove respective electrical portions (1128)via depression of use tabs (1130) until a fifth counter indicia (1136)“5” is depressed to visually indicate the used state of handle assembly(1112). In addition, EEPROM (1122) is further configured to inhibitfurther electrical powering of handle assembly (1112) with additionalreplacement shaft assemblies (14) greater than the predetermined numberof use cycles. First circuit usage indicator (1116) is therebyconfigured to inhibit inadvertently using handle assembly (1112) beyondthe predetermined number of use cycles.

In use, with respect to FIGS. 44A-44D, the clinician connects firstreplacement shaft assembly (14) to handle assembly (1112). Based on therecorded use cycles stored on EEPROM (1122), EEPROM prohibits electricalpowering of handle assembly (1112) until the clinician depresses therespective use tab (1130) that correspond to the recorded use cycle andremoves respective electrical connection (1128). Clinician depresses therespective use tab (1130) and thus treats the patient. Followingtreatment of the patient, shaft assembly (14) is disconnected fromhandle assembly (1112). Handle assembly (1112) is then prepped, such asby heating and/or sterilizing, for another surgical procedure andanother replacement shaft assembly (14) is connected to handle assembly(1112). Such reuse continues in the remaining use state until all usetabs (1130) are depressed to the used state and EEPROM (1122) prohibitsfurther electrical powering of handle assembly (1112).

An alternative, second circuit usage indicator (1216) is shown in FIGS.46A-47 for use in handle assembly (1112) of FIG. 41. Second circuitusage indicator (1216) is similar to first circuit usage indicator(1116) discussed above in most respects, but has a plurality ofremovable use tabs (1230) that include respective removable electricalconnections (1228) of an electrical circuit (1226) integrated therein.Each removable use tab (1230) is thus configured to be pulled by theclinician and removed from housing (1118) to remove electricalconnections (1228) for use by EEPROM (1122) as discussed above withrespect to first circuit usage indicator (1116). Such tabs (1130, 1230)shown in FIGS. 41-47 may thus be movable between states for indicationwhile remaining operatively connected to handle assembly (1112) orwholly removable from handle assembly (1112) for such indication.

L. First Switch Usage Indicator

FIGS. 48A-49B illustrate a twelfth exemplary ultrasonic surgicalinstrument (1310) having a handle assembly (1312) configured to beoperated up to a predetermined number of use cycles, shaft assembly (14)configured for a single use cycle of treatment, and a first switch usageindicator (1316). First switch usage indicator (1316) is integrated intoa housing (1318) of handle assembly (1312) for recording and indicatingeach respective use cycle of handle assembly (1312) in a use remainingstate to a used state. First switch usage indicator (1316) has a housingportion (1320) is configured to respond to a state of use that occursonce per usage cycle to thereby direct first switch usage indicator(1316) toward the used state. In the present example, first switch usageindicator (1316) is directed toward the used state each time shaftassembly (14) is disconnected from handle assembly (1312). Once handleassembly (1312) has been repeatedly used with replacement shaftassemblies (14), first switch usage indicator (1316) indicates the usedstate of handle assembly (1312) to the clinician. Such indication offirst switch usage indicator (1316) is visual as well as a lockout,which inhibits operation of handle assembly (1312).

First switch usage indicator (1316) includes a memory, such as an EEPROM(1322), an electromagnetic switch (1324), a pivotal blocker (1326), anda biasing element, such as a tension spring (1328), extending between ahousing mount (1330) and pivotal blocker (1326), and a visual indicia(1332). EEPROM (1322) is configured to detect and record each instancethat replacement shaft assemblies (14) are respectively connected tohandle assembly (1312). Electromagnetic switch (1324) is electricallyconnected to EEPROM (1322) and configured to be activated by EEPROM(1322) to generate a magnetic field upon initiation of the used state.Pivotal blocker (1326) is biased by tension spring (1328) in a useremaining position and configured to be moved by the magnetic field fromthe use remaining position to a used position for releasing visualindicia (1332) as discussed below.

Visual indicia (1332) includes a cylindrical body (1334) biased upwardby a biasing element, such as a compression spring (1336). Cylindricalbody (1334) is transversely aligned with an indicia window (1335) inhousing (1318) and configured to move from a recessed position belowindicia window (1335) to an extended position protruding through indiciawindow (1335). In the use remaining position, pivotal blocker (1326)releasably captures cylindrical body (1334) in the recessed positionwithin housing (1318). More particularly, tension spring (1328) bracespivotal blocker (1326) to overcome the upward force on cylindrical body(1334) by compression spring (1336) and inhibit cylindrical body (1334)from rising upward to the extended position. Cylindrical body (1334)generally remains captured in the recessed position as shown in FIG. 48Aand FIG. 48B by pivotal blocker (1326) throughout the use remainingstate to indicate to the clinician that additional use cycles forreplacement shaft assemblies (14) remain.

Once EEPROM (1322) senses removal of shaft assembly (14) on the finaluse cycle of handle assembly (1312), EEPROM (1322) operatively directselectromagnetic switch (1324) to generate the electromagnetic field.Electromagnetic field repels a magnetically responsive portion pivotalblocker (1326) and pivots pivotal blocker (1326) from the use remainingposition to the used position to release upward movement of cylindricalbody (1334) through indicia window (1335) a shown in FIG. 48B and FIG.49B. In other words, the accumulation of the electromagnetic force andcompression spring (1336) overcomes tension spring (1338) to movepivotal blocker to (1326) to the used position. In the present example,electromagnetic switch (1324) simply generates the electromagnetic fieldfor a period of time sufficient to move pivotal blocker (1326) to theused position. Electromagnetic switch (1324) thus terminates theelectric field following this period of time, but pivotal blocker (1326)remains in the used position.

Cylindrical body (1334) in the used state provides visual indication tothe clinician that all use cycles for handle assembly (1312) arecomplete. Moreover, cylindrical body (1334) cannot be depressed back tointo the housing (1318), because pivotal blocker (1326) cannot be resetto the use remaining position. Rather, compression spring (1336) willcontinue to urge cylindrical body (1334) upward for visual indication.No further electrical powering of electromagnetic switch (1324) isneeded to provide the visual indication of the used state to theclinician. In addition, EEPROM (1322) is further configured to inhibitfurther electrical powering of handle assembly (1312) with additionalreplacement shaft assemblies (14) greater than the predetermined numberof use cycles. First switch usage indicator (1316) is thereby configuredto inhibit inadvertently using handle assembly (1312) beyond thepredetermined number of use cycles. In the present example, thepredetermined number of use cycles is five use cycles with fiverespective, replacement shaft assemblies (14).

In use, with respect to FIGS. 49A-49B, the clinician connects firstreplacement shaft assembly (14) to handle assembly (1312). Followingtreatment of the patient, shaft assembly (14) is disconnected fromhandle assembly (1312) and EEPROM (1322) senses and records thedisconnection of first replacement shaft assembly (14). Handle assembly(1312) is then prepped, such as by heating and/or sterilizing, foranother surgical procedure and another replacement shaft assembly (14)is connected to handle assembly (1312). Such reuse continues in theremaining use state until EEPROM (1322) senses the disconnection ofreplacement shaft assembly (14) in the final use cycle of handleassembly (1312). EEPROM (1322) then initiates the used state bydirecting electromagnetic switch (1324) to generate the electromagneticfield and moving pivotal blocker (1326) from the use remaining positionto the used position. Compression spring (1336) then urges cylindricalbody (1334) upward through indicia window (1335) to indicate to theclinician that handle assembly (1312) is in the used state, while EEPROM(1322) inhibits further powering of handle assembly (1312) for use withanother shaft assembly (14).

M. Second Switch Usage Indicator

FIGS. 50A-50B illustrate a thirteenth exemplary ultrasonic surgicalinstrument (1410) having a handle assembly (1412) configured to beoperated up to a predetermined number of use cycles, shaft assembly (14)configured for a single use cycle of treatment, and a second switchusage indicator (1416). Second switch usage indicator (1416) isintegrated into a housing (1418) of handle assembly (1412) for recordingand indicating each respective use cycle of handle assembly (1412) in ause remaining state to a used state. Second switch usage indicator(1416) has a housing portion (1420) is configured to respond to a stateof use that occurs once per usage cycle to thereby direct second switchusage indicator (1416) toward the used state. In the present example,second switch usage indicator (1416) is directed toward the used stateeach time shaft assembly (14) is disconnected from handle assembly(1412). Once handle assembly (1412) has been repeatedly used withreplacement shaft assemblies (14), second switch usage indicator (1416)indicates the used state of handle assembly (1412) to the clinician.Such indication of second switch usage indicator (1316) is a lockout,which inhibits operation of handle assembly (1312).

Second switch usage indicator (1416) includes a memory, such as anEEPROM (1422), a solenoid switch (1424), and a translatable blocker(1426). EEPROM (1422) is configured to detect and record each instancethat replacement shaft assemblies (14) are respectively connected tohandle assembly (1412). Solenoid switch (1424) is electrically connectedto EEPROM (1422) and configured to be activated by EEPROM (1422) from anextended state to a retracted state. Translatable blocker (1426) isbiased by a compression spring (1436) from a use remaining positiontoward a used position for releasing movement of translatable blocker(1426) via solenoid switch (1424).

Generally, solenoid switch (1424) in the extended state is configured toreleasably secure translatable blocker (1426) in the use remainingposition until disconnection of shaft assembly (14) in the final usecycle. Actuating solenoid switch (1424) to the retracted state releasesmovement of translatable blocker (1426), which is positioned proximateto ultrasonic transducer (26). Translatable blocker (1426) in the usedposition extends upward into the longitudinal path of ultrasonictransducer (26) once disconnected from shaft assembly (14) to inhibitanother, replacement shaft assembly (14) from being properly connectedto ultrasonic transducer (26). The inability of the clinician toproperly connect shaft assembly (14) to handle assembly (1412) in theused state indicates such used state to the clinician. Second switchusage indicator (1416) is thereby configured to inhibit inadvertentlyusing handle assembly (1412) beyond the predetermined number of usecycles. In the present example, the predetermined number of use cyclesis five use cycles with five respective, replacement shaft assemblies(14).

In use, with respect to FIGS. 50A-50B, the clinician connects firstreplacement shaft assembly (14) to handle assembly (1412). Followingtreatment of the patient, shaft assembly (14) is disconnected fromhandle assembly (1412) and EEPROM (1322) senses and records thedisconnection of first replacement shaft assembly (14). Handle assembly(1412) is then prepped, such as by heating and/or sterilizing, foranother surgical procedure and another replacement shaft assembly (14)is connected to handle assembly (1412). Such reuse continues in theremaining use state until EEPROM (1422) senses the disconnection ofreplacement shaft assembly (14) in the final use cycle of handleassembly (1412). EEPROM (1422) then initiates the used state bydirecting solenoid switch (1424) from the extended state to theretracted state to release translatable blocker (1426) from the useremaining position toward the used position. Compression spring (1436)then urges translatable blocker (1432) upward into the longitudinal pathof ultrasonic transducer (26) to inhibit proper connection of shaftassembly (14) to handle assembly (1412) for indicating the used state tothe clinician.

III. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

An ultrasonic surgical instrument, comprising: (a) a housing configuredto removably connect to a shaft assembly; (b) an ultrasonic transducersupported by the housing and having a transducer connector configured toconnect to a waveguide for acoustically connecting the ultrasonictransducer to the waveguide, wherein the ultrasonic transducer isconfigured to be operated up to a predetermined number of use cycles;and (c) an integrated usage indicator operatively connected to thehousing and including a used state indicator, wherein the used stateindicator is configured to indicate to a user in a used state when theultrasonic transducer has been operated at least the predeterminednumber of use cycles for limiting usage of the ultrasonic transducer tothe predetermined number of use cycles.

Example 2

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator is configured to inhibit activation of the ultrasonictransducer with the shaft assembly attached therewith for inhibitingusage of the ultrasonic transducer greater than the predetermined numberof use cycles.

Example 3

The ultrasonic surgical instrument of Example 2, wherein the used stateindicator is configured to inhibit the shaft assembly from beingconnected to the housing when the ultrasonic transducer has beenoperated at least the predetermined number of use cycles.

Example 4

The ultrasonic surgical instrument of Example 1, wherein the used stateindicator is configured to inhibit the waveguide from being acousticallyconnected to the ultrasonic transducer when the ultrasonic transducerhas been operated at least the predetermined number of use cycles.

Example 5

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator has a housing portion, and wherein the housing portionof the integrated usage indicator is configured to cooperate with theshaft assembly being introduced into connection with the housing tothereby direct the integrated usage indicator toward the used state.

Example 6

The ultrasonic surgical instrument of Example 5, further comprising ashaft assembly having a shaft portion of the integrated usage indicatorconfigured to removably connect with the housing portion of theintegrated usage indicator, and wherein the shaft portion of theintegrated usage indicator is configured to direct the housing portionof the integrated usage indicator toward the used state upon connectiontherewith.

Example 7

The ultrasonic surgical instrument of Example 5, further comprising ashaft assembly having a shaft portion of the integrated usage indicatorconfigured to removably connect with the housing portion of theintegrated usage indicator, and wherein the shaft portion of theintegrated usage indicator is configured to direct the housing portionof the integrated usage indicator toward the used state upondisconnection therefrom.

Example 8

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator has a housing portion, wherein the housing portion ofthe integrate usage indicator is configured to increase in temperatureup to a predetermined temperature, and wherein the housing portion ofthe integrate usage indicator is configured to be directed toward theused state upon increasing in temperature to the predeterminedtemperature.

Example 9

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator further includes a catch connected to the housing,wherein the catch is configured to capture a detachable feature on theshaft assembly for indicating at least one of the predetermined numberof use cycles.

Example 10

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator further includes a ratchet having the used stateindicator thereon, wherein the ratchet is configured to be directed in afirst direction toward the used state upon connection of the housingwith the shaft assembly, and wherein the ratchet is ratcheted to inhibitthe ratchet from moving in a second direction opposite from the firstdirection.

Example 11

The ultrasonic surgical instrument of Example 10, wherein the ratchet isa wheel ratchet and the first and second directions are respectively afirst rotational direction and a second rotational direction.

Example 12

The ultrasonic surgical instrument of Example 10, further comprising ashaft assembly having an actuator, wherein the actuator is configured tourge the ratchet in the first direction upon connection of the shaftassembly with the housing.

Example 13

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator further includes a ratchet having the used stateindicator thereon, wherein the ratchet is configured to be directed in afirst direction toward the used state upon acoustic connection of thewaveguide to the ultrasonic transducer, wherein the ratchet is ratchetedto inhibit the ratchet from moving in a second direction opposite fromthe first direction, and wherein the ultrasonic transducer has anactuator configured to urge the ratchet in the first direction uponacoustically connecting the wave guide to the ultrasonic transducer.

Example 14

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator further includes an electrical circuit having aplurality of removable electrical connections, wherein each of theplurality of removable electrical connections is configured to beremoved with each respective predetermined number of use cycles untilindication of the used state indicator.

Example 15

The ultrasonic surgical instrument of Example 1, wherein the integratedusage indicator further includes a blocker configured to be driven froma first position to a second position upon the predetermined number ofuse cycles to thereby move the used state indicator to the used state.

Example 16

An ultrasonic surgical instrument, comprising: (a) a shaft assemblyextending from a distal end portion to a proximal end portion andincluding: (i) an end effector extending distally from the distal endportion, and (ii) an acoustic waveguide extend from the distal endportion to the proximal end portion, wherein the wave guide includes aproximally extending first threaded connection; (b) a housing configuredto removably connect to the proximal end portion of the shaft assembly;(c) an ultrasonic transducer supported by the housing and having asecond threaded connector configured to connect to the first threadedconnector of the acoustic waveguide for acoustically connecting theultrasonic transducer to the waveguide, wherein the ultrasonictransducer is configured to be operated up to a predetermined number ofuse cycles; and (d) an integrated usage indicator operatively connectedto the housing and including: (i) a use remaining indicator configuredto indicate to a clinician in a use remaining state when the ultrasonictransducer has been operated less than the predetermined number of usecycles, (ii) a used state indicator configured to indicate to theclinician in a used state when the ultrasonic transducer has beenoperated the predetermined number of use cycles, and (iii) an arresterconfigured to inhibit connection of the shaft assembly when the usedstate indicator is in the used state for limiting usage of theultrasonic transducer to the predetermined number of use cycles.

Example 17

The ultrasonic surgical instrument of Example 16, wherein the integratedusage indicator further includes a ratchet having the used stateindicator thereon, wherein the ratchet is configured to be directed in afirst direction toward the used state upon connection of the housingwith the shaft assembly, and wherein the ratchet is ratcheted to inhibitthe ratchet from moving in a second direction opposite from the firstdirection.

Example 18

A method of indicating a used state of an ultrasonic surgicalinstrument, the ultrasonic surgical instrument including: (a) a housingconfigured to removably connect to a shaft assembly, (b) an ultrasonictransducer supported by the housing and having a transducer connectorconfigured to connect to a waveguide for acoustically connecting theultrasonic transducer to the waveguide, wherein the ultrasonictransducer is configured to be operated up to a predetermined number ofuse cycles, and (c) an integrated usage indicator operatively connectedto the housing and including a used state indicator, wherein the usedstate indicator is configured to indicate to a clinician in a used statewhen the ultrasonic transducer has been operated at least thepredetermined number of use cycles for limiting usage of the ultrasonictransducer to the predetermined number of use cycles, the methodcomprising: (a) connecting the shaft assembly to the housing; (b)directing the integrated usage indicator from a use remaining statetoward the used state; and (c) indicating the used state with the usedstate indicator to the clinician when the integrated usage indicator isin the used state.

Example 19

The method of Example 18, wherein directing the integrated usageindicator further includes rotating a wheel ratchet in a first directionand inhibiting rotation of the wheel ratchet in a second direction,wherein the first direction is opposite the second direction.

Example 20

The method of Example 18, further comprising inhibiting connection ofthe shaft assembly to the housing when the integrated usage indicator isin the used state.

IV. Miscellaneous

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices described above may have application inconventional medical treatments and procedures conducted by a medicalprofessional, as well as application in robotic-assisted medicaltreatments and procedures. By way of example only, various teachingsherein may be readily incorporated into a robotic surgical system suchas the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif.Similarly, those of ordinary skill in the art will recognize thatvarious teachings herein may be readily combined with various teachingsof any of the following: U.S. Pat. No. 5,792,135, entitled “ArticulatedSurgical Instrument For Performing Minimally Invasive Surgery WithEnhanced Dexterity and Sensitivity,” issued Aug. 11, 1998, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.5,817,084, entitled “Remote Center Positioning Device with FlexibleDrive,” issued Oct. 6, 1998, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 5,878,193, entitled “Automated EndoscopeSystem for Optimal Positioning,” issued Mar. 2, 1999, the disclosure ofwhich is incorporated by reference herein; U.S. Pat. No. 6,231,565,entitled “Robotic Arm DLUS for Performing Surgical Tasks,” issued May15, 2001, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with UltrasoundCauterizing and Cutting Instrument,” issued Aug. 31, 2004, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.6,364,888, entitled “Alignment of Master and Slave in a MinimallyInvasive Surgical Apparatus,” issued Apr. 2, 2002, the disclosure ofwhich is incorporated by reference herein; U.S. Pat. No. 7,524,320,entitled “Mechanical Actuator Interface System for Robotic SurgicalTools,” issued Apr. 28, 2009, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 7,691,098, entitled “Platform Link WristMechanism,” issued Apr. 6, 2010, the disclosure of which is incorporatedby reference herein; U.S. Pat. No. 7,806,891, entitled “Repositioningand Reorientation of Master/Slave Relationship in Minimally InvasiveTelesurgery,” issued Oct. 5, 2010, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,844,789, entitled“Automated End Effector Component Reloading System for Use with aRobotic System,” issued Sep. 30, 2014, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,820,605, entitled“Robotically-Controlled Surgical Instruments,” issued Sep. 2, 2014, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.8,616,431, entitled “Shiftable Drive Interface forRobotically-Controlled Surgical Tool,” issued Dec. 31, 2013, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.8,573,461, entitled “Surgical Stapling Instruments with Cam-DrivenStaple Deployment Arrangements,” issued Nov. 5, 2013, the disclosure ofwhich is incorporated by reference herein; U.S. Pat. No. 8,602,288,entitled “Robotically-Controlled Motorized Surgical End Effector Systemwith Rotary Actuated Closure Systems Having Variable Actuation Speeds,”issued Dec. 10, 2013, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 9,301,759, entitled“Robotically-Controlled Surgical Instrument with SelectivelyArticulatable End Effector,” issued Apr. 5, 2016, the disclosure ofwhich is incorporated by reference herein; U.S. Pat. No. 8,783,541,entitled “Robotically-Controlled Surgical End Effector System,” issuedJul. 22, 2014, the disclosure of which is incorporated by referenceherein; U.S. Pat. No. 8,479,969, entitled “Drive Interface for OperablyCoupling a Manipulatable Surgical Tool to a Robot,” issued Jul. 9, 2013;U.S. Pat. No. 8,800,838, entitled “Robotically-Controlled Cable-BasedSurgical End Effectors,” issued Aug. 12, 2014, the disclosure of whichis incorporated by reference herein; and/or U.S. Pat. No. 8,573,465,entitled “Robotically-Controlled Surgical End Effector System withRotary Actuated Closure Systems,” issued Nov. 5, 2013, the disclosure ofwhich is incorporated by reference herein.

Versions of the devices described above may be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, some versions of the device may be disassembled, and anynumber of the particular pieces or parts of the device may beselectively replaced or removed in any combination. Upon cleaning and/orreplacement of particular parts, some versions of the device may bereassembled for subsequent use either at a reconditioning facility, orby a user immediately prior to a procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. An ultrasonic surgical instrument, comprising: (a) ahousing configured to removably connect to a shaft assembly; (b) anultrasonic transducer supported by the housing and having a transducerconnector configured to connect to a waveguide for acousticallyconnecting the ultrasonic transducer to the waveguide, wherein theultrasonic transducer is configured to be operated up to a predeterminednumber of use cycles; and (c) an integrated usage indicator operativelyconnected to the housing and including a used state indicator, whereinthe used state indicator is configured to indicate to a clinician in aused state when the ultrasonic transducer has been operated at least thepredetermined number of use cycles for limiting usage of the ultrasonictransducer to the predetermined number of use cycles, wherein the usedstate indicator is configured to inhibit the waveguide from beingacoustically connected to the ultrasonic transducer when the ultrasonictransducer has been operated at least the predetermined number of usecycles.
 2. The ultrasonic surgical instrument of claim 1, wherein theintegrated usage indicator is configured to inhibit activation of theultrasonic transducer with the shaft assembly attached therewith forinhibiting usage of the ultrasonic transducer greater than thepredetermined number of use cycles.
 3. The ultrasonic surgicalinstrument of claim 2, wherein the used state indicator is configured toinhibit the shaft assembly from being connected to the housing when theultrasonic transducer has been operated at least the predeterminednumber of use cycles.
 4. The ultrasonic surgical instrument of claim 1,wherein the integrated usage indicator has a housing portion, andwherein the housing portion of the integrated usage indicator isconfigured to cooperate with the shaft assembly being introduced intoconnection with the housing to thereby direct the integrated usageindicator toward the used state.
 5. The ultrasonic surgical instrumentof claim 4, further comprising a shaft assembly having a shaft portionof the integrated usage indicator configured to removably connect withthe housing portion of the integrated usage indicator, and wherein theshaft portion of the integrated usage indicator is configured to directthe housing portion of the integrated usage indicator toward the usedstate upon connection therewith.
 6. The ultrasonic surgical instrumentof claim 4, further comprising a shaft assembly having a shaft portionof the integrated usage indicator configured to removably connect withthe housing portion of the integrated usage indicator, and wherein theshaft portion of the integrated usage indicator is configured to directthe housing portion of the integrated usage indicator toward the usedstate upon disconnection therefrom.
 7. The ultrasonic surgicalinstrument of claim 1, wherein the integrated usage indicator has ahousing portion, wherein the housing portion of the integrate usageindicator is configured to increase in temperature up to a predeterminedtemperature, and wherein the housing portion of the integrate usageindicator is configured to be directed toward the used state uponincreasing in temperature to the predetermined temperature.
 8. Theultrasonic surgical instrument of claim 1, wherein the integrated usageindicator further includes a catch connected to the housing, wherein thecatch is configured to capture a detachable feature on the shaftassembly for indicating at least one of the predetermined number of usecycles.
 9. The ultrasonic surgical instrument of claim 1, wherein theintegrated usage indicator further includes a ratchet having the usedstate indicator thereon, wherein the ratchet is configured to bedirected in a first direction toward the used state upon connection ofthe housing with the shaft assembly, and wherein the ratchet isratcheted to inhibit the ratchet from moving in a second directionopposite from the first direction.
 10. The ultrasonic surgicalinstrument of claim 9, wherein the ratchet is a wheel ratchet and thefirst and second directions are respectively a first rotationaldirection and a second rotational direction.
 11. The ultrasonic surgicalinstrument of claim 9, further comprising a shaft assembly having anactuator, wherein the actuator is configured to urge the ratchet in thefirst direction upon connection of the shaft assembly with the housing.12. The ultrasonic surgical instrument of claim 1, wherein theintegrated usage indicator further includes a ratchet having the usedstate indicator thereon, wherein the ratchet is configured to bedirected in a first direction toward the used state upon acousticconnection of the waveguide to the ultrasonic transducer, wherein theratchet is ratcheted to inhibit the ratchet from moving in a seconddirection opposite from the first direction, and wherein the ultrasonictransducer has an actuator configured to urge the ratchet in the firstdirection upon acoustically connecting the wave guide to the ultrasonictransducer.
 13. The ultrasonic surgical instrument of claim 1, whereinthe integrated usage indicator further includes an electrical circuithaving a plurality of removable electrical connections, wherein each ofthe plurality of removable electrical connections is configured to beremoved with each respective predetermined number of use cycles untilindication of the used state indicator.
 14. The ultrasonic surgicalinstrument of claim 1, wherein the integrated usage indicator furtherincludes a blocker configured to be driven from a first position to asecond position upon the predetermined number of use cycles to therebymove the used state indicator to the used state.
 15. An ultrasonicsurgical instrument, comprising: (a) a shaft assembly extending from adistal end portion to a proximal end portion and including: (i) an endeffector extending distally from the distal end portion, and (ii) anacoustic waveguide extending from the distal end portion to the proximalend portion, wherein the wave guide includes a proximally extendingfirst threaded connection; (b) a housing configured to removably connectto the proximal end portion of the shaft assembly; (c) an ultrasonictransducer supported by the housing and having a second threadedconnector configured to connect to the first threaded connector of theacoustic waveguide for acoustically connecting the ultrasonic transducerto the waveguide, wherein the ultrasonic transducer is configured to beoperated up to a predetermined number of use cycles; and (d) anintegrated usage indicator operatively connected to the housing andincluding: (i) a use remaining indicator configured to indicate to aclinician in a use remaining state when the ultrasonic transducer hasbeen operated less than the predetermined number of use cycles, (ii) aused state indicator configured to indicate to the clinician in a usedstate when the ultrasonic transducer has been operated the predeterminednumber of use cycles, and (iii) an arrester configured to inhibitmechanical connection of the proximal end portion of the shaft assemblyto the housing when the used state indicator is in the used state forlimiting usage of the ultrasonic transducer to the predetermined numberof use cycles.
 16. The ultrasonic surgical instrument of claim 15,wherein the integrated usage indicator further includes a ratchet havingthe used state indicator thereon, wherein the ratchet is configured tobe directed in a first direction toward the used state upon connectionof the housing with the shaft assembly, and wherein the ratchet isratcheted to inhibit the ratchet from moving in a second directionopposite from the first direction.
 17. The ultrasonic surgicalinstrument of claim 15, wherein the arrester is further configured toinhibit inadvertent movement of the used state indicator.
 18. A methodof indicating a used state of an ultrasonic surgical instrument, theultrasonic surgical instrument including: (a) a housing configured toremovably connect to a shaft assembly, (b) an ultrasonic transducersupported by the housing and having a transducer connector configured toconnect to a waveguide for acoustically connecting the ultrasonictransducer to the waveguide, wherein the ultrasonic transducer isconfigured to be operated up to a predetermined number of use cycles,and (c) an integrated usage indicator operatively connected to thehousing and including a ratchet and a used state indicator, wherein theused state indicator is configured to indicate to a clinician in a usedstate when the ultrasonic transducer has been operated at least thepredetermined number of use cycles for limiting usage of the ultrasonictransducer to the predetermined number of use cycles, the methodcomprising: (a) connecting the shaft assembly to the housing; (b)ratcheting the ratchet of the integrated usage indicator from a useremaining state toward the used state; (c) indicating the used statewith the used state indicator to the clinician when the integrated usageindicator is in the used state.
 19. The method of claim 18, whereinratcheting the integrated usage indicator further includes rotating awheel ratchet in a first direction and inhibiting rotation of the wheelratchet in a second direction, wherein the first direction is oppositethe second direction.
 20. The method of claim 18, further comprisinginhibiting connection of the shaft assembly to the housing when theintegrated usage indicator is in the used state.